Apo-Pomalidomide

**The recommended starting dose of this medication is 4 mg taken by mouth, once daily. **When pomalidomide is taken in combination with dexamethasone and bortezomib, it is taken daily for 14 days, followed by a rest period of 7 days. This cycle is then repeated.

When pomalidomide is taken in combination with only dexamethasone, it is taken daily for 21 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.

This medication 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.

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 this medication 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 you miss a dose, and it is more than 12 hours since your missed 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 this medication 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 yellow opaque body, blue opaque cap, hard gelatin capsule, filled with yellow powder, imprinted "APO" in white ink on the cap, "P1" in black ink on the body contains 1 mg of pomalidomide. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, and pregelatinized starch; capsule shell: FD&C blue #2, gelatin, titanium dioxide, and yellow iron oxide; edible white ink: propylene glycol, shellac, sodium hydroxide, povidone, and titanium dioxide; edible black ink:  iron oxide black, potassium hydroxide, shellac, propylene glycol, and strong ammonia solution.

2 mg

Each light orange opaque body, blue opaque cap, hard gelatin capsule, filled with yellow powder, imprinted "APO" in white ink on the cap, "P2" in black ink on the body contains 2 mg of pomalidomide. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, and pregelatinized starch; capsule shell: FD&C blue #2, gelatin, titanium dioxide, iron oxide red, and iron oxide yellow; edible white ink: propylene glycol, shellac, sodium hydroxide, povidone, and titanium dioxide; edible black ink: iron oxide black, potassium hydroxide, shellac, propylene glycol, and strong ammonia solution.

3 mg

Each green opaque body, blue opaque cap, hard gelatin capsule, filled with yellow powder, imprinted "APO P3" in white ink contains 3 mg of pomalidomide. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, and pregelatinized starch; capsule shell: FD&C blue #2, gelatin, titanium dioxide, and iron oxide yellow; edible white ink: propylene glycol, shellac, sodium hydroxide, povidone, and titanium dioxide; edible white ink: propylene glycol, shellac, sodium hydroxide, povidone, and titanium dioxide.

4 mg

Each light blue opaque body, blue opaque cap, hard gelatin capsule, filled with yellow powder, imprinted "APO P4" in white ink contains 4 mg of pomalidomide. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, and pregelatinized starch; capsule shell: FD&C blue #2, gelatin, and titanium dioxide; edible white ink: propylene glycol, shellac, sodium hydroxide, povidone, and titanium dioxide.

Do not use this medication if you:

• are allergic to 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

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal, pelvic, or back pain

• bone pain

• changed sense of taste

• constipation

• cough

• diarrhea

• difficulty sleeping

• difficulty urinating

• dizziness

• falls

• feeling bloated

• headache

• heartburn or indigestion

• itching

• loss of appetite

• muscle spasms

• nausea

• nose, throat, or sinus infections

• sores or inflammation of the lips and mouth

• spinning sensation (vertigo)

• tiredness

• tremor

• vomiting

• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• chest pain

• confusion

• fever

• decreased awareness or consciousness (altered mental state)

• decreased blood pressure (e.g., dizziness, lightheadedness when rising from a sitting or lying position)

• difficulty breathing, breathlessness, or cough

• eye problems (blurred vision eye pain, vision changes)

• increased blood pressure (e.g., headache, shortness of breath)

• increased frequency of infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

• rash

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of kidney failure (e.g., decreased urine production, swelling, fatigue, abdominal pain)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• skin growths or changes in the appearance of your skin

• swelling of the feet, ankles, or lower leg

• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

• tingling, burning, numbness, or pain in the hands, arms, feet, or legs

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)

• symptoms of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms; fever, skin rash, swollen glands, decreased function of liver and other organs)

• symptoms of lung inflammation (pneumonitis) (e.g., shortness of breath, dry cough, tiredness, loss of appetite, weight loss)

• symptoms of progressive multifocal leukoencephalopathy (e.g., seizures, vision loss, trouble thinking clearly, difficulty walking)

• symptoms of a serious allergic reaction (such as difficulty breathing, hives, or swelling of the face or throat)

• symptoms of serious skin reactions (e.g., a skin rash that spreads quickly or covers a large area of the body; blisters, especially around the eyes, nose, and mouth; shedding of the skin; unexplained skin pain over a large body area)

• symptoms of tumour lysis syndrome (e.g., producing less urine, cloudy urine, kidney problems, muscle spasms, nausea, shortness of breath)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

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 this medication.

Allergic reactions: Allergic reactions, including difficulty breathing and swelling of the throat and mouth, can occur with this medication. If you experience these symptoms, get immediate medical attention.

Anemia: 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: Pomalidomide is similar to thalidomide in how it works. It is expected to cause severe and life-threatening birth defects. It is critical that 2 methods of birth control are used for all sexual contact for 4 weeks before starting pomalidomide, while taking the medication, during the "medication-free" days of a treatment cycle, and for 4 weeks after stopping the medication.

Pomalidomide is found in the semen of males taking this medication. 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 this medication, during the "medication-free" days of a treatment cycle, and for at least 4 weeks after stopping the medication. Sperm donations should be avoided while taking this medication and for at least 4 weeks after stopping the medication.

For people who could become pregnant that are taking pomalidomide, your doctor should perform pregnancy tests regularly while you are taking this medication.

Bleeding: 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: This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 this medication 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 person, it could seriously harm the unborn baby.

Drowsiness/reduced alertness: 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 this medication 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 this medication. If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with 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.

**Hypersensitivity reactions: **In rare cases, a serious hypersensitivity reaction (DRESS syndrome) may occur. This reaction includes fever, swollen glands, yellowing of the skin or eyes, flu-like symptoms with skin rash or blistering or other organ involvement. Get immediate medical attention if you have symptoms of a severe allergic reaction.

Infection: As well as killing cancer cells, 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

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

Liver function: Decreased liver function may cause this medication to build up in the body, causing side effects. This medication may also cause a decrease in liver function. If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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.

Lung inflammation: Rarely, some people taking this medication have experienced lung inflammation (interstitial lung disease), causing difficulty breathing. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking pomalidomide, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of people taking pomalidomide experiencing PML. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes, or difficulty walking, contact your doctor immediately.

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

**Tumour lysis syndrome: **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 pomalidomide. Live virus vaccines (e.g., smallpox, measles, mumps, rubella, chickenpox, shingles) are not recommended during treatment with this medication.

Pregnancy: Pomalidomide is likely to cause severe and life-threatening birth defects if a developing baby comes into contact with the medication. This medication 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 this medication, contact your doctor immediately.

**Breast-feeding: **Due to the risk of severe harm to an infant, people who are taking this medication should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children.

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

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-Pomalidomide