pomalidomide

(redirected from Pomalyst)

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 ?
Specifically, the myeloma patients who were eligible for the study had prior exposure to the two PIs, Velcade (bortezomib) and Kyprolis(carfilzomib), the two IMiDs, Revlimid and Pomalyst, and the anti-CD38 monoclonal antibody Darzalex, as well as alkylating agents, and their disease was refractory to glucocorticoids, at least one PI, at least one IMiD, Darzalex, and their most recent therapy.
The Mega M&A news on January third, when BMS announced plans to acquire Celgene in a transaction valued at approximately $74 billion, will result in leading franchises in oncology (in both solid tumors and hematologic malignancies) led by Opdivo and Yervoy as well as Revlimid and Pomalyst; Immunology and Inflammation (led by Orencia and Otezla) and Cardiovascular Disease with Eliquis.
Karyopharm Therapeutics announced three presentations highlighting new and updated data from the Phase 1b/2 STOMP study evaluating selinexor, the company's first-in-class, oral Selective Inhibitor of Nuclear Export compound, and dexamethasone in combination with standard approved multiple myeloma therapies, Kyprolis Darzalex, or Pomalyst, in patients with previously treated multiple myeloma.
Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV?negative Kaposis sarcoma.
Announces Pomalyst Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma
M2 EQUITYBITES-May 15, 2019-USFDA grants breakthrough therapy designation to Celgene's Pomalyst
With the deal, BMY builds an oncology franchises in both solid tumors and hematologic malignancies led by Opdivo and Yervoy as well as Revlimid and Pomalyst.
The combination creates leading oncology franchises in both solid tumors and hematologic malignancies led by Opdivo and Yervoy as well as Revlimid and Pomalyst. It also establishes the top-five immunology and inflammation franchise led by Orencia and Otezla and the No.
Among Celgene's drugs is Pomalyst, anti-angiogenic used as a treatment for relapsed and refractory multiple myeloma, a rare type of blood cancer."We are just beginning to understand the true power of new cancer treatments, including immuno-oncology and personalized medicines, to help patients," PhRMA said.
Pomalyst is a third-line multiple myeloma drug that saw its third-quarter sales more than double, year over year.
The seven new antineoplastic agents are adotrastuzumab emtansine (Kadcyla) for HER2-positive breast cancer; afatinib (Gilotrif) for non-small cell lung cancer; dabrafenib (Tafinlar) for unresectable or metastatic melanoma; ibrutinib (Imbruvica) for mantle cell lymphoma or chronic lymphocytic leukemia; obinutuzumab (Gazyva) for chronic lymphocytic leukemia; pomalidomide (Pomalyst) for multiple myeloma; and trametinib (Mekinist) for unresectable or metastatic melanoma.
M2 PHARMA-May 15, 2019-USFDA grants breakthrough therapy designation to Celgene's Pomalyst