lenalidomide

lenalidomide

Revlimid

Indications

Action

Pharmacokinetics

Time/action profile (↓ need for transfusions)

Contraindications/Precautions

Adverse Reactions/Side Effects

Central nervous system

• dizziness (most frequent)
• fatigue (most frequent)
• headache (most frequent)
• insomnia
• depression

Respiratory

• cough (most frequent)
• pharyngitis (most frequent)

Cardiovascular

• pulmonary embolism (life-threatening)
• edema (most frequent)
• chest pain
• deep vein thrombosis
• palpitations

Gastrointestinal

• hepatotoxicity (life-threatening)
• abdominal pain (most frequent)
• constipation (most frequent)
• diarrhea (most frequent)
• nausea (most frequent)
• vomiting (most frequent)
• abnormal taste
• anorexia
• dry mouth

Dermatologic

• stevens-johnson syndrome (life-threatening)
• toxic epidermal necrolysis (life-threatening)
• pruritus (most frequent)
• rash (most frequent)
• dry skin
• sweating

Endocrinologic

• hypothyroidism

Fluid and Electrolyte

• hypokalemia
• hypomagnesemia

Hematologic

• neutropenia
• thrombocytopenia

Musculoskeletal

• arthralgia (most frequent)
• myalgia

Miscellaneous

• angioedema (life-threatening)
• malignancy (life-threatening)
• fever (most frequent)
• chills
• tumor flare reaction
• tumor lysis syndrome

Interactions

Drug-Drug interaction

Route/Dosage

Availability

Nursing implications

Nursing assessment

• Assess pregnancy status prior to therapy. Effective contraception must be used for at least 4 wk prior to initiating therapy, during therapy, during dose interruptions, and for 4 wk following discontinuation of therapy, even with a history of infertility unless due to a hysterectomy or patient has been postmenopausal naturally for 24 consecutive months. Pregnancy tests with a sensitivity of at least 50 mIU/mL) 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 wk of use, then every 4 wk in females with a regular menstrual cycle and every 2 wk in females with an irregular cycle. Lenalidomide must be discontinued if pregnancy is suspected or confirmed. Suspected fetal exposure must be reported to FDA via MedWatch at 1-800-FDA-1088 and to manufacturer at 1-888-668–2528.
• Assess for signs of deep venous thrombosis and pulmonary edema (dyspnea, chest pain, arm or leg swelling) periodically during therapy; risk is greater when lenalidomide is administered with dexamethasone.
• Assess for skin rash. Discontinue lenalidomide if rash occurs; may cause Stevens-Johnson syndrome or Toxic Epidermal Necrolysis..
• Monitor for signs and symptoms of tumor flare reaction (tender lymph node swelling, low-grade fever, pain rash) in patients with Mantle Cell Lymphoma; may mimic disease progression.
• Lab Test Considerations: Monitor CBC with differential, platelet count, hemoglobin and hematocrit weekly for first 8 wk of therapy and at least monthly thereafter. May require dose interruption and/or reduction and use of blood support and/or growth factors.
  • May cause neutropenia with an onset of 42 days (range 4–411 days) and recovery time of 17 days (range 2–170 days). For Mutiple Myeloma starting dose is 25 mg/day — If neutropenia develops and neutrophils fall to <1000/mcl interrupt therapy, add G-CSF, and follow CBC weekly. When neutrophols return to ≥1000/mcl and neutropenia is the only toxicity, resume lenalidomide at 25 mg daily. If neutrophils return to ≥1000/mcl and if other toxicity, resume lenalidomide at 15 mg daily. For each subsequent drop <1000/mcl interrupt therapy. If neutrophils return to ≥1000/mcl, resume at 5 mg less than previous dose. Do not administer doses below 5 mg. For Myelodysplastic Syndrome starting dose is 10 mg/day —if neutropenia develops within 4 wk of starting at a 10 mg/day dose in a patient with a baseline neutrophil count (ANC) ≥1000/mcL and ANC falls to <750/mcL interrupt lenalidomide therapy and resume at 5 mg/day dose when ANC returns to ≥1000/mcL. If baseline ANC is <1000/mcL and ANC falls to <500/mcL, interrupt therapy and resume at 5 mg/day dose when ANC returns to ≥500/mcL. If neutropenia develops after 4 wk of therapy at 10 mg/day dose, and ANC <500/mcL for ≥7 days or <500/mcL associated with fever ≥38.5°C, interrupt therapy and resume at 5 mg/day when ANC returns to ≥500/mcL. If neutropenia develops at 5 mg/day dose and ANC <500/mcL for ≥7 days or <500/mcL associated with fever ≥38.5°C, interrupt therapy and resume at 2.5 mg daily when ANC returns to ≥500/mcL. For Mantle Cell Lymphomastarting dose is 25 mg/day on days 1–21 of repeated 28–day cycles — If neutrophils fall to <1000/mcl for at least 7 days or fall to <1000/mcl with fever ≥38.5°C or fall to <500/mcl, interrupt therapy and follow CBC weekly. If neutrophils return to ≥1000/mcl resume at 5 mg less than previous dose. Do not administer doses below 5 mg.
  • May cause thrombocytopenia with an onset of 28 days (range 8–290 days) and a recovery in 22 days (range 5–224 days). For Multiple Myeloma starting dose is 25 mg/day— If platelets fall to <30,000/mcl interrupt therapy and follow CBC weekly. When platelets return to ≥30,000/mcl restart lenalidomide at 15 mg/day. For each subsequent drop <30,000/mcl interrupt therapy. When platelets return to ≥30,000/mcl resume at 5 mg less than previous dose. Do not administer doses below 5 mg. For Myelodysplastic Syndrome starting dose is 10 mg/day —If thrombocytopenia develops within 4 wk of starting a 10 mg dose in a patient with a baseline of ≥100,000/mcL, and platelets fall to <50,000/mcL interrupt lenalidomide therapy and resume at 5 mg/day dose when platelets return to >50,000/mcL. If baseline was <100,000/mcL and platelets fall to 50% of baseline value interrupt therapy. If baseline ≥60,000/mcL and returns to ≥50,000/mcL or if baseline is <60,000/mcL and returns to ≥30,000/mcL resume therapy at 5 mg/day. If thrombocytopenia develops after 4 wk of treatment at 10 mg/day and platelets are <30,000/mcL or <50,000/mcL with platelet transfusions, interrupt therapy. When platelets return to ≥30,000/mcL without hemostatic failure resume therapy at 2.5 mg/day. For Mantle Cell Lymphomastarting dose is 25 mg/day on days 1–21 of repeated 28–day cycles — If platelets fall to <50,000/mcl interrupt therapy and follow CBC weekly. If platelets return to ≥50,000/mcl resume at 5 mg less than previous dose. Do not administer doses below 5 mg.
  • Monitor liver enzymes periodically during therapy. Stop therapy if enzymes are elevated; may resume when return to normal or decrease dose.
  • May cause anemia and leukopenia.
  • May cause hypokalemia, hypomagnesemia, and ↑ ALT levels.

Potential Nursing Diagnoses

Implementation

• Patients must meet the following conditions before receiving therapy: they must understand the risks and be able to carry out instructions, must be capable of complying with patient registration and patient survey in the Revlimid REMS program, must comply with contraceptive measures, have received both oral and written warnings of the risks of contraception failure and the need for two reliable forms of contraception (females) or the risks of exposing a fetus to the drug and the need to use a latex condom during sexual conduct with a female with childbearing potential (male), acknowledge understanding of these warnings in writing, and if the patient is between 12 and 18 years of age, their parent or legal guardian is to read the educational materials and agree to try to ensure compliance with conditions.
  • Lenalidomide can only be prescribed by health care providers registered in the Revlimide REMS program and only be dispensed by a pharmacy that is registered in the Revlimid REMS program.
• Oral: Administer once daily, at the same time each day, with water. Capsules should be swallowed whole; do not open, break, or chew.

Patient/Family Teaching

• Instruct patient to take lenalidomide as directed and to comply with all aspects of the Revlimid REMSprogram. Take missed doses as soon as remembered within 12 hr of dose missed. If more than 12 hrs, skip dose and return to next scheduled dose; do not administer 2 doses within 12 hrs. Inform patient that they are required to participate in a telephone survey and patient registry while taking lenalidomide. Details are available at www.REVLIMID.com.
• Caution patient not to share lenalidomide with anyone, even someone who has similar symptoms.
• Advise patient to notify health care professional if rash, shortness of breath, chest pain, or arm or leg swelling occur.
• May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Inform female patients that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) and one additional method (latex condom, diaphragm, cervical cap) AT THE SAME TIME for at least 4 wk before, during therapy and interruptions of therapy, and for 4 wk following discontinuation of therapy.
• Male patients receiving lenalidomide must always use a latex condom during and for up to 28 days following discontinuation during any contact with females with childbearing potential, even if they have undergone a successful vasectomy.
• Advise patient that they cannot donate blood and male patients cannot donate sperm while taking lenalidomide.

Evaluation/Desired Outcomes

• Decreased anemia in deletion 5q myelodysplastic syndromes with a decreased requirement for transfusion.
• Slowing of multiple myeloma progression.
• Slowing progression of mantle cell lymphoma.