Pomalidomide

Pomalidomide is a prescription medication used to treat the symptoms of Multiple Myeloma and Kaposi Sarcoma. 

• Pomalidomide is available under the following different brand names: Pomalyst

Common side effects of Pomalidomide include:

• Fever,
• Weakness,
• Tiredness,
• Nausea,
• Diarrhea,
• Constipation,
• Stuffy nose,
• Sneezing,
• Sore throat,
• Back pain, and
• Shortness of breath

Serious side effects of Pomalidomide include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Dizziness,
• Fast heartbeats,
• Fever,
• Sore throat,
• Burning eye,
• Skin pain,
• Red or purple skin rash with blistering and peeling,
• Swollen glands,
• Flu-like symptoms,
• Muscle aches,
• Severe weakness,
• Unusual bruising,
• Yellowing of the skin or eyes (jaundice),
• Numbness, tingling, or burning pain in the hands or feet,
• Chest pain or pressure,
• Pain spreading to the jaw or shoulder,
• Nausea,
• Sweating,
• Chills,
• Tiredness,
• Mouth sores,
• Skin sores,
• Unusual bleeding,
• Pale skin,
• Cold hands and feet,
• Lightheadedness,
• Shortness of breath,
• Sudden numbness or weakness (especially on one side of the body),
• Severe headache,
• Slurred speech,
• Balance problems,
• Chest pain,
• Sudden cough,
• Wheezing,
• Rapid breathing,
• Coughing up blood,
• Swelling, warmth, or redness in an arm or leg,
• Confusion,
• Weakness,
• Muscle cramps,
• Nausea,
• Vomiting,
• Fast or slow heart rate,
• Decreased urination, and
• Tingling in the hands and feet or around the mouth

Rare side effects of Pomalidomide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 1 mg
• 2 mg
• 3 mg
• 4 mg

Multiple Myeloma

Adult dosage

• 4 mg orally once a day on Days 1-21 of repeated 28-day cycles until disease progression; give in combination with low-dose dexamethasone
• Low-dose dexamethasone
  • Give orally only on Days 1, 8, 15, and 22 of each 28-day cycle
  • Below 75 years: 40 mg/day
  • Above 75 years: 20 mg/day

Kaposi Sarcoma

Adult dosage

AIDS-related Kaposi sarcoma (KS)

• 5 mg orally once a day on Days 1-21 of each 28-day cycle
• Continue until disease progression or unacceptable toxicity
• Continue HAART as HIV treatment
• KS in adults who are HIV-negative
  • 5 mg orally once a day on Days 1-21 of each 28-day cycle
  • Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pomalidomide has severe interactions with no other drugs.
• Pomalidomide has serious interactions with at least 96 other drugs.
• Pomalidomide has moderate interactions with at least 32 other drugs.
• Pomalidomide has minor interactions with the following drugs:
  • itraconazole
  • ribociclib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Pregnancy
• Hypersensitivity (.g, angioedema, anaphylaxis) to drugs or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pomalidomide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pomalidomide?”

Cautions

• Analog of known human teratogen, thalidomide, and is contraindicated during pregnancy in women, during treatment, and for 4 weeks after stopping therapy in both men and women (see Black Box Warnings and Contraindications)
• Venous and arterial thromboembolic events are reported as serious adverse reactions; patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to minimize all modifiable factors (.g., hyperlipidemia, hypertension, and smoking); in the trial, all patients were required to receive prophylaxis or antithrombotic treatment (.g, aspirin, warfarin, heparin, clopidogrel) (see Black Box Warnings)
• Hematologic toxicity reported, including neutropenia, anemia, and thrombocytopenia; monitor complete blood counts weekly for the first 8 weeks and monthly thereafter
• Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) reported; DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis; discontinue therapy for angioedema, skin exfoliation, bullae, or any other severe cutaneous reactions such as SJS, TEN or DRESS, and do not resume therapy
• Consider therapy interruption or discontinuation for Grade 2-3 skin rash; permanently discontinue therapy for Grade 4 rash, exfoliative or bullous rash, or other severe cutaneous reactions such as SJS, TEN, or DRESS
• Hepatic failure, including fatalities, has occurred; monitor LFTs monthly and discontinue drug if increased LFTs occur; after LFTs return to baseline values, treatment at a lower dose may be considered
• Hypersensitivity and severe dermatologic reactions reported; discontinue for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy
• Dizziness or confusional state reported
• Neuropathy reported
• Tumor lysis syndrome may occur; risk is increased in patients with high tumor burden before treatment
• Risk of second primary malignancies (.e, acute myelogenous leukemia) reported
• Increased mortality was observed in 2 randomized clinical trials in patients with multiple myeloma when pembrolizumab was added to a thalidomide analog and dexamethasone; treatment with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analog plus dexamethasone is not recommended outside of controlled clinical trials
• Drug interaction overview
  • Strong CYP1A2, CYP3A4, or P-GP inhibitors may increase pomalidomide exposure
  • Cigarette smoking and strong inducers of CYP1A2, CYP3A4, and P-GP may decrease pomalidomide exposure

Pregnancy and Lactation

• Contraindicated in pregnancy
• Based on the mechanism of action and findings from animal studies, embryofetal harm may occur when administered to a pregnant female
• If pregnancy does occur during treatment, immediately discontinue the drug and refer the patient to an obstetrician/ gynecologist experienced in reproductive toxicity for further evaluation and counseling
• Verify the pregnancy status of females of reproductive potential before initiation and during therapy
• Pregnancy exposure registry
  • The registry monitors pregnancy outcomes in females exposed to the drug during pregnancy as well as female partners of male patients who are exposed to drug established
  • Report any suspected fetal exposure to drug to FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436
• Contraception
  • Females of reproductive potential
  • Must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, IUD, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner’s vasectomy, and 1 additional effective contraceptive method– male latex or synthetic condom, diaphragm, or cervical cap
  • Contraception must begin 4 weeks before initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of therapy
  • Contraception is indicated even where there has been a history of infertility, unless due to a hysterectomy; refer to a qualified provider of contraceptive methods if needed
  • Males with a female partner of reproductive potential
  • Drug is present in the semen of males who take the drug
  • Must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking the drug and for up to 4 weeks after discontinuing therapy, even if they have undergone a successful vasectomy
  • Male patients taking the drug must not donate sperm
• Infertility
  • Based on findings in animals, female fertility may be compromised by treatment
• Lactation
  • No information available
  • Pomalidomide excreted in the milk of lactating rats
  • Advise females not to breastfeed during treatment