FDA approves Treatment for: Irritable Bowel Syndrome with Diarrhea (IBS-D)

Viberzi

Generic Name: eluxadoline
Date of Approval: May 27, 2015
Company: Actavis plc

Treatment for: Irritable Bowel Syndrome with Diarrhea (IBS-D)

Viberzi is a first in class treatment for irritable bowel syndrome with diarrhea, treating the characteristic symptoms of abdominal pain and diarrhea.

The U.S. Food and Drug Administration (FDA) has approved Viberzi (eluxadoline), a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi has mixed opioid receptor activity (mu receptor agonist, delta receptor antagonist, and kappa receptor agonist), and the FDA has recommended classification as a controlled substance.

MEDICATION GUIDE

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Viberzi can cause serious side effects, including:

• Sphincter of Oddi spasm. The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) to the first part of your small intestine. A sphincter of Oddi spasm can cause an increase in your liver and pancreas enzymes and inflammation of the pancreas (pancreatitis) that can cause sudden stomach-area (abdomen) pain. Your risk of having a sphincter of Oddi spasm is increased if you do not have a gallbladder. This spasm usually happens within the first week of treatment with Viberzi and usually goes away when treatment is stopped.
  Stop taking Viberzi and call your doctor if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting.
• Inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis usually go away when treatment with Viberzi is stopped. Your risk of getting pancreatitis is increased if you drink more than three alcoholic drinks a day. Limit your use of alcoholic drinks during treatment.
  Stop taking Viberzi and call your doctor if you have new or worsening stomach-area (abdomen) pain that may move to your back or shoulder, with or without nausea and vomiting.

WHAT IS VIBERZI?

Viberzi is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

Viberzi is a controlled substance (CX) because it contains eluxadoline that can be a target for people who abuse prescription medicines or street drugs. Keep your prescription in a safe place, to protect it from theft. Never give your Viberzi to anyone else, because it may harm them. Selling or giving away this medicine is against the law.

It is not known if this medicine is safe and effective in children.

An increased number of side effects, including serious side effects and stomach problems, have been reported in people 65 years and older.

WHO SHOULD NOT TAKE VIBERZI?

Do not take this medicine if you:

• have or may have had a blockage in your gallbladder or a sphincter of Oddi problem
• have or had problems with alcohol abuse, alcohol addiction, or drink more than three alcoholic drinks a day
• have had inflammation of your pancreas (pancreatitis) or other pancreas problems, including if you have had or may have had a blockage in your pancreas
• have severe liver problems
• have had long-lasting (chronic) or severe constipation, or problems caused by constipation
• have or may have had a bowel blockage (intestinal obstruction)

Talk to your doctor if you are not sure if you have any of these conditions.

BEFORE TAKING VIBERZI

Before taking this medicine, tell your doctor about all of your medical conditions, including if you:

• See Important information
• do not have a gallbladder
• have liver problems
• are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk or could harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine. Viberzi and other medicines may affect each other causing side effects.

If you are taking Viberzi you should not take:

• medicines that cause constipation including:
  • Lotronex (alosetron)
  • anticholinergic medicines
  • opioid pain medicines
  Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
• Avoid taking loperamide, a medicine used to treat diarrhea, for a long time (chronic use). You may take loperamide occasionally to treat severe diarrhea. Stop taking loperamide right away if you become constipated.

HOW SHOULD I TAKE VIBERZI?

• Take Viberzi exactly as your doctor tells you to take it.
• Take ONE tablet, two times each day with food.
• If you miss a dose, take your next dose at your regular time. Do not take two doses at the same time to make up for a missed dose.
• Do not change your dose or stop treatment unless your doctor tells you to.
• If you overdose, call your doctor or go to the nearest hospital emergency room right away.

WHAT SHOULD I AVOID WHILE TAKING VIBERZI?

• Limit your use of alcoholic drinks while you are taking Viberzi.
• If you have liver problems, do not drive, operate machinery, or do other dangerous activities until you know how Viberzi affects you.

VIBERZI SIDE EFFECTS

See Important information

The most common side effects include: constipation, nausea, and abdominal pain. Stop treatment and call your doctor if you have constipation that lasts more than four days.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE VIBERZI?

Store tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF VIBERZI

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN VIBERZI?

Active ingredient: eluxadoline

Inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).

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FDA Approves Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis

ORKAMBI

Generic Name: ivacaftor and lumacaftor
Date of Approval: July 2, 2015
Company: Vertex Pharmaceuticals Incorporated

Treatment for: Cystic Fibrosis

July 2, 2015 — The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation.

Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) is now approved to treat cystic fibrosis (CF) in patients 12 years and older, who have the F508del mutation, which causes the production of an abnormal protein that disrupts how water and chloride are transported in the body. Having two copies of this mutation (one inherited from each parent) is the leading cause of CF.

“The FDA encourages manufacturers to develop new and innovative treatments for serious rare diseases like cystic fibrosis,” said John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research. “Today’s approval significantly broadens the availability of targeted treatments for the specific defects that cause cystic fibrosis.”

Orkambi received FDA’s breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. The FDA also reviewed Orkambi under the priority review program. A priority review is conducted over six months, or less, instead of the standard 10 months, and is employed for drugs that may offer significant improvement in safety or effectiveness in treatment over available therapy in a serious disease or condition.

In addition, the FDA granted Orkambi orphan drug designation because it treats cystic fibrosis, a rare disease. Orphan drug designation provides financial incentives, like clinical trial tax credits, user fee waivers, and eligibility for market exclusivity to promote rare disease drug development.

CF is a serious genetic disorder that results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in Caucasians. The F508del mutation is the most common cause of CF. People who have two copies of the F508del mutation, one inherited from each parent, account for approximately half of the CF population in the U.S.

The safety and efficacy of Orkambi was studied in two double-blind, placebo-controlled clinical trials of 1,108 participants with CF who were 12 years and older with the F508del mutation. In both studies, participants with CF who took Orkambi, two pills taken every 12 hours, demonstrated improved lung function compared to those who took placebo.

The efficacy and safety of Orkambi have not been established in patients with CF other than those with the F508del mutation. If a patient’s genotype is unknown, an FDA cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.

The most common side effects of Orkambi include shortness of breath, upper respiratory tract infection, nausea, diarrhea, and rash. Women who took Orkambi also had increased menstrual abnormalities such as increased bleeding.

PATIENT INFORMATION

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

WHAT IS ORKAMBI?

Orkambi is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 12 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. It should not be used in patients other than those who have two copies of theF508del mutation in their CFTR gene.It is not known if this medicine is safe and effective in children under 12 years of age.

WHO SHOULD NOT TAKE ORKAMBI?

Do not take Orkambi if you take certain medicines or herbal supplements such as:

• antibiotics: rifampin (Rifamate, Rifater) or rifabutin (Mycobutin)
• seizure medications: phenobarbital, carbamazepine (Tegretol, Carbatrol, and Equetro), or phenytoin (Dilantin, Phenytek)
• sedatives/anxiolytics: triazolam (Halcion) or midazolam (Dormicum, Hypnovel, and Versed)
• immunosuppressant medicines: everolimus (Zortress), sirolimus (Rapamune), or tacrolimus (Astagraf XL, Envarsus XR, Prograf, Protopic)
• St. John’s wort (Hypericum perforatum)

Talk to your doctor before you start treatment if you take any of the medicines or supplements listed above.

WHAT SHOULD I TELL MY DOCTOR?

Before you start treatment, tell your doctor if you:

• have or have had liver problems
• have kidney problems
• are using birth control (hormonal contraceptives, including oral, injectable, transdermal, or implantable forms). Hormonal contraceptives should not be used as a method of birth control when taking Orkambi. Talk to your doctor about the best birth-control method you should use.
• are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. You and your doctor should decide if you will take Orkambi while you are pregnant.
• are breastfeeding or planning to breastfeed. It is not known if this medicine passes into your breast milk. You and your doctor should decide if you will take Orkambi while you are breastfeeding.

Orkambi may affect the way other medicines work, and vice versa. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because the dose of Orkambi may need to be adjusted when taken with certain medications.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

• antifungal medications such as ketoconazole (Nizoral), itraconazole (Sporanox), posaconazole (Noxafil), or voriconazole (Vfend)
• antibiotics such as telithromycin (Ketek), clarithromycin (Biaxin), or erythromycin (Ery-Tab)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE ORKAMBI?

• Take Orkambi exactly as your doctor tells you to take it.
• Always the tablets with fat-containing foods such as eggs, avocados, nuts, butter, peanut butter, cheese pizza, whole-milk dairy products, (such as whole milk, cheese, and yogurt), etc.
• Take your doses twelve hours apart.
• Each box contains four weekly cartons. Each carton contains seven daily blister strips. Each blister strip contains four tablets so you can take two tablets for the morning and two tablets for the evening.
• You may cut along the dotted line to separate your morning dose from your evening dose.
• Unpeel the paper backing from a blister strip to remove two tablets and take them with fat-containing food in the morning, and repeat again in the evening, twelve hours later.
• If you miss a dose within six hours of when you usually take it, take your dose with fat-containing food as soon as possible.
• If you miss a dose and it is more than six hours after the time you usually take it, skip that dose only and take the next dose when you usually take it. Do not take two doses at the same time to make up for your missed dose.
• Tell your doctor if you stop treatment for more than one week. Your doctor may need to change your dose of Orkambi or other medicines you take.

WHAT SHOULD I AVOID WHILE TAKING ORKAMBI?

It is unknown if Orkambi causes dizziness. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how it affects you.

ORKAMBI SIDE EFFECTS

Orkambi can cause serious side effects.

High liver enzymes in the blood, which can be a sign of liver injury, have been reported in patients receiving Orkambi.

Your doctor will do blood tests to check your liver:

• before you start treatment
• every three months during your first year of treatment
• every year while you are taking Orkambi

Call your doctor right away if you have any of the following symptoms of liver problems:

• pain or discomfort in the upper right stomach (abdominal) area
• yellowing of your skin or the white part of your eyes
• loss of appetite
• nausea or vomiting
• dark, amber-colored urine
• confusion

Respiratory events such as shortness of breath or chest tightness were observed in patients when starting Orkambi. If you have poor lung function your doctor may monitor you more closely when you start treatment.

Abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving ivacaftor, a component of Orkambi. Your doctor should perform eye examinations prior to and during treatment to look for cataracts.

The most common side effects include:

• shortness of breath and/or chest tightness
• upper respiratory tract infection (common cold), including sore throat, stuffy or runny nose
• gastrointestinal symptoms, including nausea, diarrhea, or gas
• rash
• fatigue
• flu or flu-like symptoms
• increase in muscle enzyme levels
• irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ORKAMBI?

• Store Orkambi at room temperature between 68°F to 77°F (20°C to 25°C).

Do not use Orkambi after the expiration date on the package.

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ORKAMBI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes only the most important information. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ORKAMBI?

Active ingredients: lumacaftor and ivacaftor

Inactive ingredients: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; povidone; and sodium lauryl sulfate.

The tablet film coat contains: carmine, FD&C Blue #1, FD&C Blue #2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

The printing ink contains: ammonium hydroxide, iron oxide black, propylene glycol, and shellac.

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FDA Approves Entresto

July 7, 2015 — The U.S. Food and Drug Administration today approved Entresto(sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

Entresto

Generic Name: sacubitril and valsartan
Date of Approval: July 7, 2015
Company: Novartis Pharmaceuticals Corporation

In clinical trials, Entresto was shown to significantly reduce the rate of heart failure deaths and hospitalizations compared to the ACE inhibitor enalapril.The U.S. Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan), a neprilysin inhibitor and angiotensin receptor blocker (ARB) combination used to reduce the risk of hospitalization and cardiovascular death in patients with chronic heart failure. Entresto tablets are available in three dosage strengths administered twice daily, usually in conjunction with other heart failure therapies.

PATIENT INFORMATION

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Entresto can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant during treatment, tell your doctor right away.

WHAT IS ENTRESTO?

Entresto is a prescription medicine used to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure.It is usually used with other heart failure therapies, in place of an ACE inhibitor or other ARB therapy.Heart failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.It is not known if Entresto is safe and effective in children.

WHO SHOULD NOT TAKE ENTRESTO?

Do not take Entresto if you:

• are allergic to sacubitril or valsartan or any of the inactive ingredients. See the end of this Patient Information leaflet for a complete list of ingredients.
• have had an allergic reaction including swelling of your face, lips, tongue, throat or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).
• take an ACE inhibitor medicine. Do not take Entresto for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before you start treatment if you are not sure if you take an ACE inhibitor medicine.
• have diabetes and take a medicine that contains aliskiren.

BEFORE TAKING ENTRESTO

Before you start treatment, tell your doctor about all of your medical conditions, including if you:

• have kidney or liver problems
• are pregnant or plan to become pregnant. See Important information.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your doctor should decide if you will take Entresto or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Entresto with other medicines can cause serious side effects. Especially tell your doctor if you take:

• potassium supplements or a salt substitute
• nonsteroidal anti-inflammatory drugs (NSAIDs)
• lithium
• other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE ENTRESTO?

• Take this medicine exactly as your doctor tells you to take it.
• Take your dose two times each day. Your doctor may change your dose during treatment.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you overdose, call your doctor right away.

ENTRESTO SIDE EFFECTS

Entresto may cause serious side effects including:

• See Important information.
• Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take Entresto again if you have had angioedema during treatment. Black patients may have a higher risk of having angioedema during treatment. People who have had angioedema prior to treatment may have a higher risk of having angioedema during treatment. See Who should not take Entresto?
• Low blood pressure (hypotension). Low blood pressure may be more common if you also take water pills. Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue.
• Kidney problems. Your doctor will check your kidney function during your treatment.If you have changes in your kidney function tests, you may need a lower dose, or may need to stop treatment for a period of time.
• Increased amount of potassium in your blood. Your doctor will check your potassium blood level during treatment.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ENTRESTO?

• Store Entresto at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect the tablets from moisture.
• Store the tablets in the original container.

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ENTRESTO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ENTRESTO?

Active ingredients: sacubitril and valsartan

Inactive ingredients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate (vegetable origin), talc, and colloidal silicon dioxide.
Film coat: hypromellose, titanium dioxide (E 171), Macrogol 4000, talc, iron oxide red (E 172). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E 172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E 172).

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FDA Approves Odomzo

Odomzo (sonidegib) Capsules

Company: Novartis Pharmaceuticals Corporation
Date of Approval: July 24, 2015
Treatment for: Basal Cell Carcinoma

Odomzo is the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma.

The U.S. Food and Drug Administration (FDA) has approved Odomzo (sonidegib), an oral hedgehog pathway inhibitor for the treatment of locally advanced basal cell carcinoma (laBCC) that has returned after surgery or radiation therapy, or for patients who cannot undergo surgery or radiation therapy. It joins Erivedge (vismodegib) as the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma.

MEDICATION GUIDE

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Odomzo can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

For females who can become pregnant:

• You should talk to your healthcare provider about the risks to your unborn child.
• Your healthcare provider will do a pregnancy test before you start treatment.
• In order to avoid pregnancy, you should use birth control during treatment, and for at least 20 months after your final dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed.
• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

• It is not known if Odomzo is present in semen. Do not donate semen while you are taking Odomzo and for at least 8 months after your final dose.
• You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment and for at least 8 months after your final dose to protect your female partner from being exposed to Odomzo.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Odomzo.

Exposure to Odomzo during pregnancy:

If you think that you or your female partner may have been exposed to Odomzo during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment, you or your healthcare provider should report your pregnancy to Novartis Pharmaceuticals Corporation at 1-888-669-6682.

WHAT IS ODOMZO?

Odomzo is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has come back following surgery or radiation or that cannot be treated with surgery or radiation.

It is not known if it is safe and effective in children.

BEFORE TAKING ODOMZO

Before you take Odomzo, tell your healthcare provider if you:

• have muscle pain or spasms, or have a history of a muscle disorder called rhabdomyolysis or myopathy
• have any other medical conditions
• are pregnant or plan to become pregnant. See Important information.
• are breastfeeding or plan to breastfeed. It is not known if Odomzo passes into your breast milk. Do not breastfeed during treatment and for 20 months after your final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

HOW SHOULD I TAKE ODOMZO?

• Take this medicine exactly as your healthcare provider tells you.
• Take Odomzo one time each day, at least one hour before or two hours after a meal.
• If you miss a dose, skip the missed dose. Take your next dose as scheduled.

WHAT SHOULD I AVOID WHILE TAKING ODOMZO?

• Do not donate blood or blood products during treatment and for 20 months after your final dose.
• Do not donate semen during treatment and for at least 8 months after your final dose.

ODOMZO SIDE EFFECTS

Odomzo can cause serious side effects, including:

• See Important information.
• Muscle Problems. Muscle spasms and muscle pain are common with Odomzo, but can also sometimes be symptoms of serious muscle problems. Odomzo can increase your risk of muscle pain and, rarely a serious condition caused by injury to the muscles (rhabdomyolysis) that can lead to kidney damage. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain or tenderness, dark urine, or decreased amount of urine during treatment.

Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking Odomzo, during treatment, and if you develop muscle problems.

The most common side effects include:

• hair loss
• change in taste
• tiredness
• nausea
• diarrhea
• weight loss
• decreased appetite
• vomiting
• stomach area (abdominal pain)
• itching
• headache

Odomzo can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ODOMZO?

• Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ODOMZO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ODOMZO?

Active ingredient: sonidegib

Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer, and sodium lauryl sulfate. The capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.

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