Pomalyst

The recommended starting dose of Pomalyst (Pomalidomide) is 4 mg taken by mouth, once daily. When it is taken in combination with the medication Dexamethasone, it is normally taken daily for 21 days followed by a rest period of 7 days. This cycle is then repeated.

Pomalyst (Pomalidomide) may also be used in combination with dexamethasone and the medication Bortezomib. With this regimen, Pomalyst (Pomalidomide) is taken daily for 14 days, followed by a rest period of 7 days. This cycle is then repeated.

Depending on how well you tolerate the medication, your doctor may adjust your dose.

Pomalyst (Pomalidomide) should be taken once a day at approximately the same time each day.

The capsules should be swallowed whole with water. Do not open the capsules, crush them, or chew them.

Pomalyst (Pomalidomide) may be taken with food or on an empty stomach

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are administering the medication without consulting your doctor.

It is important to take Pomalyst (Pomalidomide) exactly as prescribed by your doctor. If you miss a dose, and it is less than 12 hours since your missed dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Pomalyst (Pomalidomide) in its original package, at room temperature. Do not remove the capsule from its original package until you are ready to take a dose. Protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

1 mg
Each dark blue and yellow opaque capsule, imprinted "POML 1 mg" in white and black ink contains 1 mg of Pomalyst (Pomalidomide). Nonmedicinal ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. Capsule: gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide, and white and black ink.

2 mg
Each dark blue and orange opaque capsule, imprinted "POML 2 mg" in white ink contains 2 mg of Pomalyst (Pomalidomide). Nonmedicinal ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. Capsule: gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide, FD&C Red No. 3, and white ink.

3 mg
Each dark blue and green opaque capsule, imprinted "POML 3 mg" in white ink contains 3 mg of Pomalyst (Pomalidomide). Nonmedicinal ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. Capsule: gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide, and white ink.

4 mg
Each blue and dark blue opaque capsule, imprinted "POML 4 mg" in white ink contains 4 mg of Pomalyst (Pomalidomide). Nonmedicinal ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. Capsule: gelatin, titanium dioxide, FD&C Blue No. 2, FD&C Blue No. 1, and white ink.

Do not use Pomalyst (Pomalidomide) if you:

• are allergic to Pomalyst (Pomalidomide) or any ingredients of the medication
• are allergic to thalidomide or Lenalidomide
• or your partner are pregnant or may become pregnant
• are breast-feeding
• are male and not able to follow the necessary birth control requirements

There may be an interaction between Pomalyst (Pomalidomide) and any of the following:

• alcohol
• azelastine
• Abiraterone
• Amiodarone
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• antiseizure medications (e.g., Carbamazepine, Clobazam, Ethosuximide, , Levetiracetam, Phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baclofen
• barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• certain biologics (e.g., Anakinra, Natalizumab, Tocilizumab)
• birth control pills
• bisphosphonates (e.g., Alendronate, etidronate)
• boceprevir
• Bosentan
• brimonidine
• Buprenorphine
• Buspirone
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• chloral hydrate
• cigarette smoking
• conivaptan
• Cyclosporine
• Deferasirox
• dexamethasone
• droperidol
• echinacea
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Gemfibrozil
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• kava kava
• Leflunomide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Mefloquine
• Methadone
• methoxsalen
• metyrosine
• mifepristone
• Mirtazapine
• muscle relaxants (e.g., Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• peginterferon Alfa-2b
• Pimecrolimus
• Pramipexole
• Pregabalin
• Primaquine progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)quinidine
• rifampin
• Roflumilast
• Tacrolimus
• tolcapone
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Nortriptyline)
• vaccines
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Pomalyst (Pomalidomide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Pomalyst (Pomalidomide).

Anemia: Pomalyst (Pomalidomide) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: Pomalyst (Pomalidomide) is similar to thalidomide in how it works. It is expected to cause severe and life-threatening birth defects. It is critical that two methods of birth control are used for all sexual contact for 4 weeks before starting Pomalyst (Pomalidomide), while taking the medication and for 4 weeks after stopping the medication.

Pomalyst (Pomalidomide) is found in the semen of males taking Pomalyst (Pomalidomide). Exposure to the medication in this manner can cause birth defects, stillbirths and miscarriages for a pregnant partner. It is critical that condoms be used during any sexual contact while taking Pomalyst (Pomalidomide), during the "medication-free" days of a treatment cycle and for at least 4 weeks after stopping the medication.

For women taking Pomalyst (Pomalidomide), your doctor should perform pregnancy tests regularly while you are taking Pomalyst (Pomalidomide).

Bleeding: Pomalyst (Pomalidomide) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood Clots: Pomalyst (Pomalidomide) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Pomalyst (Pomalidomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pomalyst (Pomalidomide), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Donating blood: Do not donate blood while you are using Pomalyst (Pomalidomide) and for at least 4 weeks after stopping the medication to ensure that the medication has completely left your body. If your blood was given to a pregnant woman, it could seriously harm the unborn baby.

Drowsiness/reduced alertness: Pomalyst (Pomalidomide) may cause fatigue, confusion or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Pomalyst (Pomalidomide) affects you.

Hepatitis B: People infected with hepatitis B virus (an infection that can damage the liver) may have a relapse of their condition while taking Pomalyst (Pomalidomide). If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with Pomalyst (Pomalidomide) and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Infection: As well as killing cancer cells, Pomalyst (Pomalidomide) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.

If you are taking other medications that reduce the effectiveness of your immune system you may be at a greater risk of developing a severe, or life-threatening infection. Discuss with your doctor how Pomalyst (Pomalidomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pomalyst (Pomalidomide), and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Pomalyst (Pomalidomide) to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how Pomalyst (Pomalidomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pomalyst (Pomalidomide), and whether any special monitoring is needed.

Liver Function: Pomalyst (Pomalidomide) may cause a decrease in liver function. If you have liver disease, discuss with your doctor how Pomalyst (Pomalidomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pomalyst (Pomalidomide), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unusually unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Secondary cancers: Your doctor will monitor you for the development of other types of cancer while using Pomalyst (Pomalidomide) and after treatment has stopped. Like other medications to treat cancer, it is possible that Pomalyst (Pomalidomide) may permit another type of cancer to develop. If you have concerns, talk to your doctor about the risks and benefits of using Pomalyst (Pomalidomide).

Tumour Lysis Syndrome: Pomalyst (Pomalidomide), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea or shortness of breath, or notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Vaccines: Vaccines may be ineffective if given during treatment with Pomalyst (Pomalidomide). Live virus vaccines (e.g., Smallpox, Measles, Mumps, rubella, Chickenpox, Shingles) are not recommended during treatment with Pomalyst (Pomalidomide).

Pregnancy: Pomalyst (Pomalidomide) is likely to cause severe and life-threatening birth defects if a developing baby comes into contact with the medication. Pomalyst (Pomalidomide) should not be used if you or your partner is pregnant or planning to become pregnant. If you become pregnant while you or your partner is using Pomalyst (Pomalidomide), contact your doctor immediately.

Breast-feeding: Due to the risk of severe harm to an infant, women who are taking Pomalyst (Pomalidomide) should not breast-feed.

Children: The safety and effectiveness of using Pomalyst (Pomalidomide) have not been established for children.

Seniors: There is limited information about the safety of Pomalyst (Pomalidomide) use (combined with dexamethasone) by seniors. The dexamethasone may increase the risk of infection and a lower dose may be needed.