Lenalid 5/Lenalid 10/Lenalid 15/Lenalid 25

Lenalid 5/Lenalid 10/Lenalid 15/Lenalid 25

lenalidomide

Manufacturer:

Natco Pharma

Distributor:

Natco Lifesciences
Concise Prescribing Info
Contents
Lenalidomide
Indications/Uses
In combination w/ dexamethasone in patients w/ multiple myeloma who are not eligible for stem cell transplant. Lenalid 5/Lenalid 10 Treatment in patients who require blood transfusions due to myelodysplastic syndromes in which part of chromosome 5 is missing.
Dosage/Direction for Use
Multiple myeloma Initially 25 mg daily on days 1-21 of 28-day cycles in combination w/ dexamethasone. Myelodysplastic syndrome Initially 10 mg daily on days 1-21 of 28-day cycles. Take the cap at about the same time each day.
Administration
May be taken with or without food: Swallow whole w/ water. Do not break/chew/open the cap.
Contraindications
Hypersensitivity to lenalidomide, pomalidomide, thalidomide or to lactose. Patients w/ chronic lymphocytic leukemia (CLL). Pregnancy & lactation. Patients at risk of becoming pregnant. Myelodysplastic syndromes: Do not start treatment in patients w/ <50 x 109/L platelet levels.
Special Precautions
Serious side effects may occur eg, birth defects; death of an unborn baby, spontaneous abortion; neutropenia & thrombocytopenia; DVT, pulmonary embolism, heart attacks & stroke; liver problems; anaphylaxis. Patient should not give blood during therapy & 4 wk after discontinuation. Caution in patients w/ kidney, liver, or blood problems; present or history of heart (irregular heartbeat, heart attack) problems; smokers; patients w/ high BP or cholesterol levels; previous viral infection (including shingles &/or hepatitis B); previous organ transplantation. Women of childbearing potential must use 2 effective methods of contraception starting at least 4 wk before treatment, during treatment, during treatment interruptions, & for at least 4 wk after stopping treatment. Perform pregnancy tests 7-14 days prior to starting treatment, w/in 24 hr of starting treatment, once wkly for the 1st 4 wk of treatment, once every 4 wk (or once every 2 wk if patient's period is irregular) during treatment & during interruption, & 4 wk after stopping treatment. Male patients should use a condom every sexual intercourse w/ a woman who is pregnant or can get pregnant, even if vasectomized. Condom must be used while taking lenalidomide, during treatment interruptions, & for 4 wk after stopping treatment. Do not donate sperm during treatment & for 4 wk after stopping treatment. Not recommended in childn <18 yr. Myelodysplastic syndromes: Reports of 2nd cancers (eg, skin, blood, & solid tumor cancers).
Adverse Reactions
Tiredness/lethargy, fever, joint pain & muscle cramps, abdominal pain, difficulty breathing/breathlessness, difficulty sleeping, diarrhea, dizziness, swelling of arms or legs, cough, headache, nausea, skin rash, back pain, loss of appetite, swelling, vomiting. Bruise, increased sweating, dry mouth, flatulence, skin redness, loose stools, toothache, hair loss, skin lesions, dry eye, eye redness, fall. Multiple myeloma: Chest & other infections, muscle weakness, pain, hard stools/difficult to pass, bleeding from gums or other sites, numbness/abnormal sensations, cloudy (cataracts) or blurred vision, wt loss, frequent hunger w/ excessive thirst & urination, altered taste, heart palpitations/awareness of abnormal heart rhythm, chest pain, mouth pain, general feeling of discomfort or uneasiness, sore throat, shaking, confusion, wt gain, depression, arm pain w/ arm or leg swelling, reduced sense of touch, irritability, "pins & needles" in hands & feet, heartburn. Dry skin, mouth inflammation, high BP (headache), hoarse voice, stuffy nose, itchy skin, lightheadedness or dizziness or fainting, dehydration, mood changes, hiccups, runny nose, swelling face, muscle spasm, fever w/ shaking, face redness, impaired balance, canker sores, bone pain, skin cancer, skin discoloration, decreased urination, hot flashes, increased tears, skin wound, decreased sex drive, nervousness, difficulty moving limbs, walking or speaking (stroke), hives, memory impairment, difficulty swallowing, eye itch, rash, ringing in ears, allergic reaction, bedsores, blood in urine, deafness, increased hair growth, walking abnormally, increased appetite, mental status changes, non-coordinated muscle movement, painful or frequent urination, pale skin, urgent need to urinate, wheezing, wound. Myelodysplastic syndromes: Decrease in WBC, decrease in platelets, itchy skin, infection of the nasal passages, constipation, decrease in RBC, infection of the pharynx, URTI, nose bleed, lack or loss of strength, dry skin, pain in arm or leg, UTI, pneumonia, decrease in blood K level, bronchitis, sinus infection, night sweats, muscle pain. Pain, upper abdominal pain, arm &/or leg swelling, acquired decreased thyroid activity, high BP, difficult or painful urination, allergy (rhinitis), flu, decreased sensitivity to stimulation, ruptured blood vessels, chest pain, rigors, foot pain, distortion of sense of taste, loss of sensation in limbs, decrease in blood Mg level, wt loss, infection under the skin, depression, sensation of pricking, tingling, or creeping on the skin, heart palpitations, acute leukemia, ear pain, eye pain.
Drug Interactions
May interact w/ digoxin, HRT & hormonal contraception (estrogens & progestins).
MIMS Class
Cancer Immunotherapy
ATC Classification
L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Lenalid 10 cap 10 mg
Packing/Price
28's
Form
Lenalid 15 cap 15 mg
Packing/Price
21's
Form
Lenalid 25 cap 25 mg
Packing/Price
21's
Form
Lenalid 5 cap 5 mg
Packing/Price
28's
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