pomalidomide

pomalidomide

(pom-a-lid-oh-mide) ,

Pomalyst

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: immunomodulatory agents
Pregnancy Category: X

Indications

Treatment of multiple myeloma in patients who have received at least 2 prior therapies including lenalidomide and bortezomib and have progressed on or within 60 days of completion of previous treatment.

Action

Inhibits proliferation and induced apoptosis of hematopoietic tumor cells. Proliferation of resistant multiple myeloma cell lines and may act synergistically with dexamethasone. Enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines.

Therapeutic effects

Decreased progression of multiple myeloma.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Enters semen.
Metabolism and Excretion: Primarily metabolized in the liver by CYP1A2 and CYP3A4 with some metabolism by CYP2C19 and CYP2D6. Metabolites excreted in urine and feces. Minimal amounts excreted unchanged in urine.
Half-life: Normal subjects—9.5 hr; myeloma patients—7.5 hr.

Time/action profile

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Contraindications/Precautions

Contraindicated in: Hypersensitivity, cross-sensitivity with thalidomide may occur; Blood should not be donated; Serum creatinine >3.0 mg/dL; Serum bilirubin >2.0 mg/dL and AST/ALT >3.0 × ULN; Obstetric: May cause fetal harm/death; Lactation: Should not be used by nursing mothers.
Use Cautiously in: Patients with reproductive potential (pregnancy should be excluded/prevented, contraception should be practiced by both male and female patients); Pediatric: Safety and effectiveness not been established.

Adverse Reactions/Side Effects

Central nervous system

  • confusion (most frequent)
  • dizziness (most frequent)
  • insomnia (most frequent)
  • fatigue
  • weakness

Respiratory

  • dyspnea (most frequent)

Cardiovascular

  • deep vein thrombosis/pulmonary embolism (life-threatening)
  • peripheral edema (most frequent)

Gastrointestinal

  • ↓ appetite (most frequent)
  • constipation (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)

Genitourinary

  • renal failure

Dermatologic

  • dry skin (most frequent)
  • hyperhidrosis (most frequent)
  • night sweats (most frequent)
  • pruritus (most frequent)
  • rash (most frequent)

Endocrinologic

  • hyperglycemia (most frequent)

Fluid and Electrolyte

  • hypercalcemia (most frequent)
  • hypocalcemia (most frequent)
  • hypokalemia (most frequent)
  • hyponatremia (most frequent)

Hematologic

  • anemia
  • neutropenia
  • thrombocytopenia (life-threatening)
  • leukopenia (most frequent)
  • lymphopenia (most frequent)

Musculoskeletal

  • arthralgia (most frequent)
  • back pain (most frequent)
  • bone pain (most frequent)
  • muscle spasms (most frequent)
  • muscle weakness (most frequent)
  • musculoskeletal pain (most frequent)
  • pain in extremity (most frequent)

Neurologic

  • neuropathy
  • tremor

Miscellaneous

  • infection
  • malignancy
  • fever (most frequent)
  • hypersensitivity reactions (most frequent)
  • chills

Interactions

Drug-Drug interaction

Blood levels and toxicity may be ↑ drugs that inhibit CYP3A, CYP1A2 or P-gp inhibitors including ketoconazole ; avoid concurrent use.Blood levels and effectiveness may be ↓ by drugs that are strong inducers of CYP1A2, CYP3A or P-gp, including rifampin ; avoid concurrent use.Cigarette smoking may ↓ blood levels and effectiveness.

Route/Dosage

Oral (Adults) 4 mg daily on days 1–21 of 28-day cycle, repeated until disease progression; modifications recommended for neutropenia and/or thrombocytopenia.

Availability

Capsules: 1 mg, 2 mg, 3 mg, 4 mg

Nursing implications

Nursing assessment

  • Assess pregnancy status prior to therapy. Effective contraception must be used for at least 4 wks prior to initiating therapy, during therapy, during dose interruptions, and for 4 wks following discontinuation of therapy. Pregnancy tests must be done within 10–14 days and within 24 hrs of starting therapy. Once treatment has started pregnancy tests should occur weekly during first 4 wks of use, then every 4 wks in females with a regular menstrual cycle and every 2 wks in females with an irregular cycle. Pomalidomide must be discontinued if pregnancy is suspected or confirmed.
  • Assess for signs of deep venous thrombosis and pulmonary edema (dyspnea, chest pain, arm or leg swelling) periodically during therapy). Prophylactic anticoagulation may be considered.
  • Lab Test Considerations: Monitor CBC with differential, platelet count, hemoglobin and hematocrit weekly for first 8 wks of therapy and at least monthly thereafter. May require dose reduction.
    • May cause neutropenia. If absolute neutrophil count (ANC) ≥500/mcL or febrile neutropenia (fever ≥38.5° and ANC <1000/mcL interrupt pomalidomide therapy and follow CBC weekly. If ANC returns to ≥500/mcL resume pomalidomide at 3 mg/day. For each subsequent drop <500/mcL, interrupt therapy and resume at 1 mg/day less than the previous dose when ANC returns to ≥500/mcL.
    • May cause thrombocytopenia. If platelets fall to <25,000/mcL interrupt pomalidomide therapy and follow CBC weekly. When platelets return to >50,000/mcL, resume at 3 mg/day. For each subsequent drop <25000/mcL, interrupt therapy and resume at 1 mg/day less than the previous dose when platelet count returns to ≥50,000/mcL.
    • May cause anemia, leukopenia, lymphopenia.
    • May cause hyperglycemia, hyponatremia, hypokalemia, hypocalcamia, and hypercalcemia.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Pomalidomide is only available through POMALYST REMS program. Prescribers and pharmacies must be certified. Patients must sign a Patient-Prescriber form and comply with REMS requirements. Female patients who are not pregnant must comply with pregnancy testing and contraception requirements and males must comply with contraception requirements.
  • Oral: Administer with water on an empty stomach, at least 2 hrs before and 2 hrs after meals. Swallow capsule whole; do not open, break, or chew.

Patient/Family Teaching

  • Instruct patient to take pomalidomide as directed daily at the same time each day. Missed doses may be taken up to 12 hrs after the time it would be normally be taken. If more than 12 hrs, skip dose and take regularly scheduled dose the next day; do not double doses.
  • Inform female patients that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) and one additional method (latex or synthetic condom, diaphragm, cervical cap) for at least 4 wks before, during therapy and interruptions of therapy, and for 4 wks following discontinuation of therapy.
  • Male patients receiving pomalidomide must always use a latex or synthetic condom during any contact with females with child-bearing potential, even if they have undergone a successful vasectomy.
  • Caution patient not to share pomalidomide with anyone, even someone who has similar symptoms.
  • Advise patient to notify health care professional if shortness of breath, chest pain, or arm or leg swelling occur.
  • May cause dizziness and confusion. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient that they cannot donate blood and male patients cannot donate sperm while taking pomalidomide and for 1 month following therapy.

Evaluation/Desired Outcomes

  • Reduction in clinical and laboratory symptoms of multiple myeloma.
References in periodicals archive ?
The Phase 1b trial will study Oncolytics' immuno-viral therapy, Reolysin (pelareorep), in combination with Celgene Corp.'s immunomodulatory drugs (IMiDs), Imnovid (pomalidomide) or Revlimid (lenalidomide), as a rescue treatment in relapsing myeloma patients.
Abstract #8001; Oral; Friday, June 1, 2:57 p.m., E450, Pomalidomide, Bortezomib, and low-dose dexamethasone (PVd) vs.
In the US, Pomalyst (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The ELOQUENT-3 trial is the first randomized trial comparing the standard of care, pomalidomide and low dose dexamethasone, with and without the addition of a monoclonal antibody.
Celgene Corporation announced results from the OPTIMISMM study, a phase III, randomized, open-label, international clinical study of the investigational combination regimen of POMALYST (pomalidomide), bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one prior treatment including lenalidomide.
M2 PHARMA-May 10, 2017-Natco Pharma launches generic pomalidomide capsules for myeloma
Pomalidomide is not currently approved in the US for the treatment of multiple myeloma.
The positive results from the MM-003 study of oral pomalidomide have led to the positive opinion.
Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Contract notice: supply of exclusive medicines: azacitidine 100 mg (vial), pomalidomide 3 mg (21 capsules), pomalidomide 4 mg (21 capsules)
The company said it plans to launch Pomalidomide Celgene under the trade name "IMNOVID" in the EU, upon submission of a regulatory notification to the European Medicines Agency (EMA) to change the trade name.
- New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) has consulted with the US Food and Drug Administration (FDA) and agreed on amendments to the CheckMate-602 study protocol, following which the FDA lifted a partial clinical hold placed on the randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma, the company said.