Classes
DEA Class; Rx
Common Brand Names; Pomalyst
- Antineoplastics, Angiogenesis Inhibitor
Description
Biologic response modifier that is a thalidomide analog
Used for the treatment of adult patients with multiple myeloma or Kaposi sarcoma
Risk of birth defects or embryo-fetal death if used during pregnancy; routine testing required; prescribers, pharmacies
Indications
Indicated in combination with dexamethasone, for multiple myeloma (MM) in patients who have received at least 2 prior therapies (including lenalidomide and a proteasome inhibitor) and have disease progression on or within 60 days of completion of the last therapy3
Kaposi Sarcoma
AIDS-related Kaposi sarcoma (KS)
- Indicated for AIDS-related KS in patients who failed highly active antiretroviral therapy (HAART)
- Continue until disease progression or unacceptable toxicity
- Continue HAART as HIV treatment
KS in adults who are HIV-negative
- Indicated for KS in adults who are HIV-negative
Contraindications
Pregnancy
Hypersensitivity (eg, angioedema, anaphylaxis) to drug or excipients
Adverse Effects
- Fatigue and asthenia (55-63%)
- Neutropenia (47-52%)
- Dyspnea (34-45%)
- Anemia (38-39%)
- Constipation (35-36%)
- Nausea (22-36%)
- Diarrhea (33-34%)
- Back pain (30-32%)
- Upper respiratory tract infection (25-32%)
- Pyrexia (19-30%)
- Pneumonia (23-29%)
- Thrombocytopenia (23-25%)
- Peripheral edema (16-23%)
- Musculoskeletal chest pain (20-22%)
- Decreased appetite (18-22%)
- Rash (16-22%)
- Cough (14-21%)
- Hypercalcemia (12-21%)
- Dizziness (17-20%)
- Muscle spasms (19%)
- Leukopenia (11-18%)
- Arthralgia (15-16%)
- Urinary tract infection (8-16%)
- Hyperhidrosis (6-16%)
- Hyperglycemia (12-15%)
- Musculoskeletal pain (11-15%)
- Epistaxis (11-15%)
- Pruritus (11-15%)
- Increased blood creatinine (11-15%)
- Renal failure (10-15%)
- Lymphopenia (4-15%)
- Vomiting (13-14%)
- Decreased weight (8-14%)
- Insomnia (7-14%)
- Pain in extremity (5-14%)
- Hyponatremia (10-13%)
Warnings
Analog of known human teratogen, thalidomide, and is contraindicated during pregnancy in women, and 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 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 (e.g., hyperlipidemia, hypertension, smoking); in the trial, all patients were required to receive prophylaxis or antithrombotic treatment (eg, 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 for other severe cutaneous reactions such as SJS, TEN or DRESS
Hepatic failure, including fatalities, have 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
Pregnancy and Lactation
Contraindicated in pregnancy
No information available
Maximum Dosage
Multiple myeloma, 4 mg/day PO; Kaposi sarcoma, 5 mg/day PO.
Multiple myeloma, 4 mg/day PO; Kaposi sarcoma, 5 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Pomalidomide
capsule
- 1mg
- 2mg
- 3mg
- 4mg