ACTEMRA (tocilizumab) Injection
Company: Genentech USA, Inc.
Date of Approval: January 8, 2010
Treatment for: Rheumatoid Arthritis
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults.
FDA Approves Actemra
The United States (US) Food and Drug Administration (FDA) approved Actemra (tocilizumab, RoActemra in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Actemra, the result of a research & development collaboration with Chugai, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
Actemra Medication Guide
Read this Medication Guide before you start Actemra and before each infusion. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Actemra?
Actemra can cause serious side effects including:
1. Serious Infections
Actemra is a medicine that affects your immune system. Actemra can lower the ability of your immune system to fight infections. Some people have serious infections while taking Actemra, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
o Your doctor should test you for TB before starting Actemra.
o Your doctor should monitor you closely for signs and symptoms of TB during treatment with Actemra.
You should not start taking Actemra if you have any kind of infection unless your healthcare provider says it is okay.
Before starting Actemra, tell your healthcare provider if you:
o think you have an infection or have symptoms of an infection such as:
fever, sweating, or chills
muscle aches
cough
shortness of breath
blood in phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than normal
feel very tired
o are being treated for an infection
o get a lot of infections or have infections that keep coming back
o have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
o have TB, or have been in close contact with someone with TB
o live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Actemra. Ask your healthcare provider, if you do not know if you have lived in an area where these infections are common.
o have or have had hepatitis B.
After starting Actemra, call your healthcare provider right away if you have any symptoms of an infection. Actemra can make you more likely to get infections or make worse any infection that you have.
2. Tears (perforation) of the stomach or intestines.
o Before taking Actemra, tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Actemra get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
o Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
3. Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving Actemra and every 4 to 8 weeks during treatment to check for the following side effects of Actemra:
o low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
o low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
o increase in certain liver function tests.
You should not receive Actemra if your neutrophil or platelet counts are too low or your liver function tests are too high.
Your healthcare provider may stop your Actemra treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Actemra, and then every 6 months after that. Normal cholesterol levels are important to good heart health.
4. Cancer.
Actemra may decrease the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers. Tell your healthcare provider if you have ever had any type of cancer. See "What are the possible side effects with Actemra?" for more information about side effects.
What is Actemra?
Actemra is a prescription medicine called an Interleukin-6 (IL-6) receptor inhibitor. Actemra is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well.
It is not known if Actemra is safe and effective in children.
What should I tell my healthcare provider before receiving Actemra?
Actemra may not be right for you. Before starting Actemra, tell your healthcare provider if you:
• have an infection. See "What is the most important information I should know about Actemra?"
• have liver problems
• have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
• have or had a condition that affects your nervous system, such as multiple sclerosis
• have recently received or are scheduled to receive a vaccine. People who take Actemra should not receive live vaccines. People taking Actemra can receive non-live vaccines
• plan to have surgery or a medical procedure
• have any other medical conditions
• plan to become pregnant or are pregnant. It is not known if Actemra will harm your unborn baby.
• Pregnancy Registry: Genentech has a registry for pregnant women who take Actemra. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Actemra, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.
• plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take Actemra or breast-feed. You should not do both.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Actemra and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take:
• any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi), while you are taking Actemra. Taking Actemra with these medicines may increase your risk of infection.
• medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I receive Actemra?
• You will receive Actemra from a healthcare provider through a needle placed in a vein in your arm (IV or intravenous infusion). The infusion will take about 1 hour to give you the full dose of medicine.
• You will receive a dose of Actemra about every 4 weeks.
• If you miss a scheduled dose of Actemra, ask your healthcare provider when to schedule your next infusion.
• While taking Actemra, you may continue to use other medicines that help treat your rheumatoid arthritis such as methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
• Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.
What are the possible side effects with Actemra?
Actemra can cause serious side effects, including:
• See "What is the most important information I should know about Actemra?"
• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use Actemra. This happens with other biologic medicines used to treat RA. Your doctor may do blood tests before you start treatment with Actemra and while you are using Actemra. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
o feel very tired
o skin or eyes look yellow
o little or no appetite
o vomiting
o clay-colored bowel movements
o fevers
o chills
o stomach discomfort
o muscle aches
o dark urine
o skin rash
• Nervous system problems. Multiple Sclerosis has been diagnosed rarely in people who take Actemra. It is not known what effect Actemra may have on some nervous system disorders.
• Allergic Reactions. Serious allergic reactions can happen with Actemra. These reactions may not happen with your first infusion, and may happen with future infusions of Actemra. Tell your healthcare provider right away if you have any of the following signs of a serious allergic reaction:
o shortness of breath or trouble breathing
o skin rash
o swelling of the lips, tongue, or face
o chest pain
o feeling dizzy or faint
Common side effects of Actemra include:
• upper respiratory tract infections (common cold, sinus infections)
• headache
• increased blood pressure (hypertension)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Actemra. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
See also: Actemra side effects in more detail
General information about Actemra
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Actemra.
If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Actemra that is written for health professionals.
For more information, go to www.actemra.com or call 1-800-ACTEMRA.
What are the ingredients in Actemra?
Active ingredient: tocilizumab
Inactive ingredients: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.
Sunday, February 21, 2010
Xiaflex
Xiaflex (collagenase clostridium histolyticum)
Company: BioSpecifics Technologies Corp.
Date of Approval: February 3, 2010
Treatment for: Dupuytren's Contracture
Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.
Company: BioSpecifics Technologies Corp.
Date of Approval: February 3, 2010
Treatment for: Dupuytren's Contracture
Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.
Victoza
Victoza
Generic Name: liraglutide
Date of Approval: January 25, 2010
Company: Novo Nordisk A/S
DA Approves Victoza
The United States Food and Drug Administration (FDA) has approved Victoza (liraglutide) once-daily injection for treating type 2 diabetes. Victoza is indicated to help lower blood sugar levels when coupled with diet, exercise and other diabetes medicines. It is not recommended as an initial therapy for patients who have not been able to control their diabetes with diet and exercise alone.
Victoza Medication Guide
Read this Medication Guide and Patient Instructions for Use that come with Victoza before you start using Victoza and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have questions about Victoza after reading this information, ask your healthcare provider or pharmacist.
What is the most important information I should know about Victoza?
Serious side effects may happen in people who take Victoza, including:
1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Victoza caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.
o Before you start taking Victoza, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take Victoza if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Victoza.
o While taking Victoza, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
2. Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
Before taking Victoza, tell your healthcare provider if you have had:
o pancreatitis
o stones in your gallbladder (gallstones)
o a history of alcoholism
o high blood triglyceride levels
These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Victoza.
While taking Victoza:
Stop taking Victoza and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.
What is Victoza?
• Victoza is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise.
• Victoza is not recommended as the first choice of medication for treating diabetes.
• Victoza is not insulin.
• It is not known if Victoza is safe and effective when used with insulin.
• Victoza is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
• It is not known if Victoza is safe and effective in children. Victoza is not recommended for use in children.
Who should not use Victoza?
Do not use Victoza if:
• you or any of your family members have a history of medullary thyroid cancer.
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body. Talk with your healthcare provider if you are not sure if you have any of these conditions.
What should I tell my healthcare provider before using Victoza?
Before taking Victoza, tell your healthcare provider if you:
• have any of the conditions listed in the section "What is the most important information I should know about Victoza?"
• are allergic to liraglutide or any of the other ingredients in Victoza. See the end of this Medication Guide for a list of ingredients in Victoza.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• have or have had kidney or liver problems.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Victoza will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Victoza.
• are breastfeeding or plan to breastfeed. It is not known if Victoza passes into your breast milk. You and your healthcare provider should decide if you will take Victoza or breastfeed. You should not do both without talking with your healthcare provider first.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Victoza slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Victoza may affect the way some medicines work and some other medicines may affect the way Victoza works. Tell your healthcare provider if you take other diabetes medicines, especially sulfonylurea medicines or insulin.
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use Victoza?
• Use Victoza exactly as prescribed by your healthcare provider. Your dose should be increased after using Victoza for one week. After that, do not change your dose unless your healthcare provider tells you to.
• Victoza is injected 1 time each day, at any time during the day.
• You can take Victoza with or without food.
• Victoza comes in a prefilled pen.
• Your healthcare provider must teach you how to inject Victoza before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist. See the Patient Instructions for Use that come with this Medication Guide for detailed information about the right way to use your Victoza pen.
• Pen needles are not included. You may need a prescription to get pen needles from your pharmacist. Ask your healthcare provider which needle size is best for you.
• When starting a new prefilled Victoza pen, you must follow the "First Time Use for Each New Pen" (see the detailed Patient Instructions for Use that comes with this Medication Guide). You only need to do this 1 time with each new pen. You should also do this if you drop your pen. If you do the "First Time Use for Each New Pen" before each injection, you will run out of medicine too soon.
• Inject your dose of Victoza under the skin (subcutaneous injection) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your healthcare provider. Do not inject into a vein or muscle.
• If you take too much Victoza, call your healthcare provider right away. Too much Victoza may cause severe nausea and vomiting.
• Follow your healthcare provider’s instructions for diet, exercise, how often to test your blood sugar, and when to get your HbA1c checked. If you stop using Victoza your blood sugar levels may increase. First talk to your healthcare provider if you want to stop taking Victoza.
• Your dose of diabetes medicines may need to be changed if your body is under certain types of stress. Tell your healthcare provider if you:
o have fever
o have trauma
o have an infection
o plan to have or have had surgery
• Never share your Victoza pen or needles with another person. You may give an infection to them, or get an infection from them.
Victoza side effects
Victoza may cause serious side effects, including:
• See "What is the most important information I should know about Victoza?"
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take Victoza with another medicine that can cause low blood sugar, such as a sulfonylurea. In some people, the blood sugar may get so low that they need another person to help them. The dose of your sulfonylurea medicine may need to be lowered while you use Victoza. Signs and symptoms of low blood sugar may include:
o shakiness
o sweating
o headache
o drowsiness
o weakness
o dizziness
o confusion
o irritability
o hunger
o fast heartbeat
o feeling jittery
Talk to your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people who are around you a lot know how to recognize and treat low blood sugar.
Common side effects of Victoza include:
• headache
• nausea
• diarrhea
Nausea is most common when first starting Victoza, but decreases over time in most people as their body gets used to the medicine.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the side effects with Victoza. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Victoza side effects in more detail
How should I store Victoza?
Before use:
• Store your new, unused Victoza pen in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).
• Do not freeze Victoza or use Victoza if it has been frozen. Do not store Victoza near the refrigerator cooling element.
Pen in use:
• Store your Victoza pen for 30 days either at 59ºF to 86ºF (15ºC to 30ºC), or in a refrigerator at 36ºF to 46ºF (2°C to 8°C).
• When carrying the pen away from home, store the pen at a temperature between 59ºF to 86ºF (15ºC to 30ºC) and keep it dry.
• If Victoza has been exposed to temperatures above 86ºF (30ºC), it should be thrown away.
• Protect your Victoza pen from heat and sunlight.
• Keep the pen cap on when your Victoza pen is not in use.
• Use your Victoza pen within 30 days after the first day it is stored outside the refrigerator. After these 30 days, throw away your Victoza pen even if some medicine is left in the pen.
• Do not use Victoza after the expiration date printed on the carton. Do not store the Victoza pen with the needle attached. Always safely remove and safely throw away the needle after each injection. This may help prevent contamination, infection and leakage. It also helps to make sure that you get the correct dose of Victoza. See the Patient Instructions for Use for information about how to dispose of used pen needles and used Victoza pens.
Keep your Victoza pen, pen needles, and all medicines out of the reach of children.
General information about Victoza
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Victoza for a condition for which it was not prescribed. Do not give Victoza to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information you should know about using Victoza. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Victoza that is written for health professionals. For more information, go to victoza.com or call 1-877-484-2869.
What are the ingredients in Victoza?
Active Ingredient: liraglutide
Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection.
Generic Name: liraglutide
Date of Approval: January 25, 2010
Company: Novo Nordisk A/S
DA Approves Victoza
The United States Food and Drug Administration (FDA) has approved Victoza (liraglutide) once-daily injection for treating type 2 diabetes. Victoza is indicated to help lower blood sugar levels when coupled with diet, exercise and other diabetes medicines. It is not recommended as an initial therapy for patients who have not been able to control their diabetes with diet and exercise alone.
Victoza Medication Guide
Read this Medication Guide and Patient Instructions for Use that come with Victoza before you start using Victoza and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have questions about Victoza after reading this information, ask your healthcare provider or pharmacist.
What is the most important information I should know about Victoza?
Serious side effects may happen in people who take Victoza, including:
1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Victoza caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.
o Before you start taking Victoza, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take Victoza if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Victoza.
o While taking Victoza, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
2. Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
Before taking Victoza, tell your healthcare provider if you have had:
o pancreatitis
o stones in your gallbladder (gallstones)
o a history of alcoholism
o high blood triglyceride levels
These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Victoza.
While taking Victoza:
Stop taking Victoza and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.
What is Victoza?
• Victoza is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise.
• Victoza is not recommended as the first choice of medication for treating diabetes.
• Victoza is not insulin.
• It is not known if Victoza is safe and effective when used with insulin.
• Victoza is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
• It is not known if Victoza is safe and effective in children. Victoza is not recommended for use in children.
Who should not use Victoza?
Do not use Victoza if:
• you or any of your family members have a history of medullary thyroid cancer.
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body. Talk with your healthcare provider if you are not sure if you have any of these conditions.
What should I tell my healthcare provider before using Victoza?
Before taking Victoza, tell your healthcare provider if you:
• have any of the conditions listed in the section "What is the most important information I should know about Victoza?"
• are allergic to liraglutide or any of the other ingredients in Victoza. See the end of this Medication Guide for a list of ingredients in Victoza.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• have or have had kidney or liver problems.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Victoza will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Victoza.
• are breastfeeding or plan to breastfeed. It is not known if Victoza passes into your breast milk. You and your healthcare provider should decide if you will take Victoza or breastfeed. You should not do both without talking with your healthcare provider first.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Victoza slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Victoza may affect the way some medicines work and some other medicines may affect the way Victoza works. Tell your healthcare provider if you take other diabetes medicines, especially sulfonylurea medicines or insulin.
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use Victoza?
• Use Victoza exactly as prescribed by your healthcare provider. Your dose should be increased after using Victoza for one week. After that, do not change your dose unless your healthcare provider tells you to.
• Victoza is injected 1 time each day, at any time during the day.
• You can take Victoza with or without food.
• Victoza comes in a prefilled pen.
• Your healthcare provider must teach you how to inject Victoza before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist. See the Patient Instructions for Use that come with this Medication Guide for detailed information about the right way to use your Victoza pen.
• Pen needles are not included. You may need a prescription to get pen needles from your pharmacist. Ask your healthcare provider which needle size is best for you.
• When starting a new prefilled Victoza pen, you must follow the "First Time Use for Each New Pen" (see the detailed Patient Instructions for Use that comes with this Medication Guide). You only need to do this 1 time with each new pen. You should also do this if you drop your pen. If you do the "First Time Use for Each New Pen" before each injection, you will run out of medicine too soon.
• Inject your dose of Victoza under the skin (subcutaneous injection) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your healthcare provider. Do not inject into a vein or muscle.
• If you take too much Victoza, call your healthcare provider right away. Too much Victoza may cause severe nausea and vomiting.
• Follow your healthcare provider’s instructions for diet, exercise, how often to test your blood sugar, and when to get your HbA1c checked. If you stop using Victoza your blood sugar levels may increase. First talk to your healthcare provider if you want to stop taking Victoza.
• Your dose of diabetes medicines may need to be changed if your body is under certain types of stress. Tell your healthcare provider if you:
o have fever
o have trauma
o have an infection
o plan to have or have had surgery
• Never share your Victoza pen or needles with another person. You may give an infection to them, or get an infection from them.
Victoza side effects
Victoza may cause serious side effects, including:
• See "What is the most important information I should know about Victoza?"
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take Victoza with another medicine that can cause low blood sugar, such as a sulfonylurea. In some people, the blood sugar may get so low that they need another person to help them. The dose of your sulfonylurea medicine may need to be lowered while you use Victoza. Signs and symptoms of low blood sugar may include:
o shakiness
o sweating
o headache
o drowsiness
o weakness
o dizziness
o confusion
o irritability
o hunger
o fast heartbeat
o feeling jittery
Talk to your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people who are around you a lot know how to recognize and treat low blood sugar.
Common side effects of Victoza include:
• headache
• nausea
• diarrhea
Nausea is most common when first starting Victoza, but decreases over time in most people as their body gets used to the medicine.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the side effects with Victoza. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Victoza side effects in more detail
How should I store Victoza?
Before use:
• Store your new, unused Victoza pen in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).
• Do not freeze Victoza or use Victoza if it has been frozen. Do not store Victoza near the refrigerator cooling element.
Pen in use:
• Store your Victoza pen for 30 days either at 59ºF to 86ºF (15ºC to 30ºC), or in a refrigerator at 36ºF to 46ºF (2°C to 8°C).
• When carrying the pen away from home, store the pen at a temperature between 59ºF to 86ºF (15ºC to 30ºC) and keep it dry.
• If Victoza has been exposed to temperatures above 86ºF (30ºC), it should be thrown away.
• Protect your Victoza pen from heat and sunlight.
• Keep the pen cap on when your Victoza pen is not in use.
• Use your Victoza pen within 30 days after the first day it is stored outside the refrigerator. After these 30 days, throw away your Victoza pen even if some medicine is left in the pen.
• Do not use Victoza after the expiration date printed on the carton. Do not store the Victoza pen with the needle attached. Always safely remove and safely throw away the needle after each injection. This may help prevent contamination, infection and leakage. It also helps to make sure that you get the correct dose of Victoza. See the Patient Instructions for Use for information about how to dispose of used pen needles and used Victoza pens.
Keep your Victoza pen, pen needles, and all medicines out of the reach of children.
General information about Victoza
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Victoza for a condition for which it was not prescribed. Do not give Victoza to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information you should know about using Victoza. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Victoza that is written for health professionals. For more information, go to victoza.com or call 1-877-484-2869.
What are the ingredients in Victoza?
Active Ingredient: liraglutide
Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection.
Xenical
Xenical is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).
Do not take Xenical if you are allergic to orlistat, or if you have gallbladder problems, or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).
Before taking Xenical, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight-loss medications (prescription or over-the-counter).
Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor. Xenical should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a secure place where others cannot get to it.
Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.
Take Xenical during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Xenical is usually taken 3 times daily. If you skip a meal or you eat a meal that does not contain any fat, skip your Xenical dose for that meal. The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. Avoid a diet that is high in fat. High-fat meals taken in combination with Xenical can increase your risk of unpleasant side effects on your stomach or intestines.
Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.
Your doctor may recommend you take vitamin and mineral supplements while you are taking Xenical. This medication can make it harder for your body to absorb fat-soluble vitamins, such as vitamins A, D, E, and K. Follow your doctor's instructions about the type of multi-vitamin or mineral supplement to use. Take the supplement at least 2 hours before or after you take Xenical.
Do not take Xenical if you are allergic to orlistat, or if you have:
• chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or
• gallbladder problems.
Before taking Xenical, tell your doctor if you are allergic to any drugs, or if you have:
• an underactive thyroid;
• a history of gallstones;
• a history of pancreatitis;
• liver disease;
• type 1 or type 2 diabetes;
• an eating disorder (anorexia or bulimia); or
• if you take any other weight-loss medications (prescription or over-the-counter).
If you have any of these conditions, you may not be able to use Xenical, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Xenical can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use Xenical without telling your doctor if you are breast-feeding a baby.
Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor. Xenical should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a secure place where others cannot get to it.
Take Xenical exactly as directed on the label, or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Xenical comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.
Take Xenical with a full glass of water. Take Xenical during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Xenical is usually taken 3 times daily.
If you skip a meal or you eat a meal that does not contain any fat, skip your Xenical dose for that meal.
The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.
Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.
Your doctor may recommend you take vitamin and mineral supplements while you are taking Xenical. This medication can make it harder for your body to absorb fat-soluble vitamins, such as vitamins A, D, E, and K. Follow your doctor's instructions about the type of multi-vitamin or mineral supplement to use.
Take the supplement at least 2 hours before or after you take Xenical.
Store Xenical at room temperature away from moisture and heat. Keep the bottle tightly closed.
Keep track of how many pills have been used from each new bottle of this medicine. Xenical is a drug that may be misused as a weight-loss aid, and you should be aware if any person in the household is using this medicine improperly or without a prescription.
Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
If you miss a meal, or if you have a meal without fat, you can skip your dose of Xenical for that meal also.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Xenical and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.
The following side effects occur commonly with the use of Xenical. They are the natural effects of Xenical's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with Xenical:
• oily spotting in your undergarments;
• oily or fatty stools;
• orange or brown colored oil in your stool;
• gas with discharge, an oily discharge;
• loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;
• an increased number of bowel movements;
• stomach pain, nausea, vomiting, diarrhea, rectal pain; or
• weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).
Other side effects that may occur while taking Xenical include:
• problems with your teeth or gums;
• cold symptoms such as stuffy nose, sneezing, cough;
• fever, chills, sore throat, flu symptoms;
• headache, back pain; or
• mild skin rash.
Before taking Xenical, tell your doctor if you are using any of the following drugs:
• insulin or diabetes medications you take by mouth;
• cyclosporine (Gengraf, Neoral, Sandimmune);
• digoxin (digitalis, Lanoxin, Lanoxicaps);
• levothyroxine (Synthroid, Levoxyl, Levothroid); or
• a blood thinner such as warfarin (Coumadin).
If you are using any of these drugs, you may not be able to use Xenical, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect Xenical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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