PracticeUpdate: Oncology - Winter 2018

(lenalidomide) capsules

1 †

Continuous REVLIMID/dex in transplant ineligible ndMM 2,3

† 5.8 years to second-line treatment, achieved by 1 in 2 patients 1 Based on the median TTNT with Continuous REVLIMID/dex in the 48% of patients who achieved ≥VGPR in the FIRST Trial (n=260) 1 † Twice as many patients progression-free at 4 years 1 With Continuous REVLIMID/dex vs. MPT (32.6% vs. 13.6%; p<0.00001) 1

Think FIRST *

*FIRST: Frontline Investigation of REVLIMID and dexamethasone vs. Standard Thalidomide trial.

Before prescribing Revlimid ® (lenalidomide) please refer to the full Product Information which is available at http://www.guildlink.com.au/gc/ws/celgene/pi.cfm?product=cjprevli Teratogenic Effects: Revlimid (lenalidomide) is structurally related to thalidomide. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy whilst taking Revlimid (lenalidomide), during dose interruptions, and for 4 weeks after stopping the medication. PBS Information: Authority required for the treatment of transplant-ineligible newly diagnosed or previously treated multiple myeloma. Refer to PBS schedule for full authority information. This Product is not listed on the PBS for maintenance treatment post stem cell transplant in newly diagnosed multiple myeloma. Revlimid ® (lenalidomide) Capsules Minimum Product Information (Multiple Myeloma) Indications: Revlimid is indicated for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation. Revlimid is indicated for the maintenance treatment of patients with NDMM who have undergone autologous stem cell transplantation. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy. Contraindications: Pregnant women; women of childbearing potential unless all of the conditions of the i-access ® Program are met; hypersensitivity to the active substance or to any of the excipients. Precautions: Pregnancy (Category X) To avoid the risk of foetal exposure, Revlimid is only available under a restricted distribution program ( i-access ® ); myocardial infarction; venous and arterial thromboembolism; neutropenia and thrombocytopenia - regular blood count monitoring recommended (see full PI); peripheral neuropathy; tumour lysis syndrome (TLS) and tumour flare reaction (TFR); allergic reactions and serious skin reactions (including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reactionwith eosinophilia and systemic symptoms (DRESS)); atrial fibrillation; impaired thyroid function; lactose intolerance; hepatic impairment; renal impairment; elderly; paediatric use; second primary malignancies (SPM). Interactions with Other Medicines: Erythropoietic agents or other agents that may increase the risk of thrombosis; myelosuppressive agents; digoxin. (Possible interactions: oral contraceptives; warfarin). Adverse Effects: Nasopharyngitis; pharyngitis; pneumonia; bronchitis; upper respiratory tract infection; viral, bacterial and fungal infections (including opportunistic infections); sinusitis; sepsis; tumour flare; squamous cell carcinoma of skin; basal cell carcinoma; neutropenias; thrombocytopenia; anaemia; leukopenias; febrile neutropenia; pancytopenia; hypersensitivity; hypothyroidism; decreased appetite; hyperglycaemia; electrolyte disturbances (see full PI); dehydration; iron overload; diabetes mellitus; gout; insomnia; depression; peripheral neuropathies (excluding motor neuropathy); dizziness; tremor; dysgeusia; headache; lethargy; syncope; cerebrovascular accident; cataracts; blurred vision; vertigo; atrial fibrillation; myocardial infarction; cardiac failure; tachycardia; venous thromboembolic events; hypertension; hypotension; haematoma; dyspnoea; epistaxis; cough; respiratory distress; pneumonitis; gastrointestinal disturbances; abdominal pain; dry mouth; toothache; abnormal liver function tests; cholestasis; pruritus; rash; dry skin; hyperhidrosis; night sweats; erythema; musculoskeletal and connective tissue pain and discomfort; muscle spasms; arthralgia; bone pain; myalgia; muscular weakness; renal failure; pyrexia; influenza-like illness syndrome; fatigue; asthenia; oedema (including peripheral); chest pain; weight decreased; fall; contusion. Post marketing experience: SJS; TEN; DRESS; TLS; TFR; myocardial infarction; hyperthyroidism; transient abnormal liver lab tests; hepatic failure (including acute); hepatitis (see full PI); viral reactivation (such as hepatitis B virus or herpes zoster); allergic conditions (angioedema, urticaria); acute graft-versus-host disease (following allogenic hematopoietic transplant); solid organ transplant rejection. Dose and Method of Administration: Recommended starting dose for transplant ineligible NDMM and previously treated multiple myeloma is 25mg orally daily on days 1-21 of repeated 28-day cycles (see full PI for further information). Recommended starting dose for maintenance post-transplant NDMM is 10 mg orally once daily continuously, increased to 15mg/day after 3 months, if tolerated. See full PI for further information on dosing. Dosing is continued or modified based upon clinical and laboratory findings, and to manage grade 3 or 4 toxicities (see full PI). Min PI MM V5.1.1 ABBREVIATIONS: Continuous: treatment until disease progression or intolerance; dex: dexamethasone; MPT: melphalan, prednisone, thalidomide; ndMM: newly diagnosed multiple myeloma; TTNT: time to next treatment. VGPR: very good partial response.

REFERENCES: 1. Facon T, et al. Blood 2018;131:301–10. 2. Benboubker L, et al. N Eng J Med 2014;371:906–17. 3. REVLIMID ® Product Information. Celgene Pty Ltd ABN 42 118 998 771. Level 15, 60 City Road, Southbank, VIC 3006, Australia. Tel: 1800 CELGENE (1800 235 4363) www.celgene.com.au ® Registered Trademark. AU-REV0148. BB-CEL2674. Date prepared: July 2018.