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Dosing Guide | NINLARO® (Ixazomib)

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Dosing Guide | NINLARO® (Ixazomib) DOSING GUIDE Indication NINLARO® (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Please see Important Safety Information on pages 20-21 and accompanying NINLARO (ixazomib) full Prescribing Information. The NINLARO® (ixazomib) regimen* offers the convenience of oral administration1-3 Dosing • The recommended starting dose of NINLARO is 4 mg (one capsule) in combination with lenalidomide and dexamethasone1† CONTENTS: Communicating with your patients Tips and reminders have been included in this brochure to DOSING facilitate communication with patients. You can recognize Pages 3-5 them by their orange callout box. DOSING CONSIDERATIONS Pages 6-9 Share the following information at the start of treatment to ensure patients and caregivers are well informed: ADVERSE REACTIONS Pages 10-14 • Drug and indication • Dose and dosing schedule • Start date DOSE MODIFICATIONS • Handling instructions Pages 15-19 • Administration and what to do if a dose is missed or too much NINLARO is taken • Food and drug interactions SAFETY • Side effects and management Pages 20-21 *The NINLARO regimen includes NINLARO+lenalidomide+dexamethasone. †A 3-mg starting dose is recommended for patients with moderate or severe hepatic impairment and patients with severe renal impairment or end-stage renal disease requiring dialysis. A 2.3-mg dose is also available for subsequent dose reductions due to adverse reactions (ARs). Please see Important Safety Information on pages 20-21 and accompanying NINLARO (ixazomib) 2 full Prescribing Information. Plan for individualized adherence strategies4 Dosing schedule1 • Have patients build a routine and take • The recommended dosing schedule for each 28-day medication during a certain activity every day treatment cycle of: • Encourage patients to keep track of each dose — NINLARO is 4 mg (one capsule) administered orally by keeping a medication diary once a week on days 1, 8, and 15 • Help set alarms (eg, watches, smartphones, — Lenalidomide is 25 mg administered orally daily on text/call reminders) days 1 through 21 — Dexamethasone is 40 mg administered orally on Treatment should be continued until disease days 1, 8, 15, and 22 progression or unacceptable toxicity1 NINLARO® (ixazomib) is available in the following capsule strengths1: • 4 mg: Light orange gelatin capsule imprinted with the logo on the cap and 4 mg on the body in black ink • 3 mg: Light gray gelatin capsule imprinted with the logo on the cap and 3 mg on the body in black ink • 2.3 mg: Light pink gelatin capsule imprinted with the logo on the cap and 2.3 mg on the body in black ink NINLARO Lenalidomide Dexamethasone (4 mg, 3 mg, 2.3 mg) (25 mg) (40 mg) • Advise patients to take NINLARO once a week on the same day and at approximately the same time for the first 3 weeks of a 4-week cycle. The importance of carefully following all dosage instructions should be discussed with patients starting treatment. Advise patients to take the recommended dosage as directed because overdosage has led to deaths Please see Important Safety Information on For more information on dosing pages 20-21 and accompanying NINLARO (ixazomib) administration requirements, see the 4 full Prescribing Information. next page. NINLARO® (ixazomib) dosing considerations1 Considerations prior to initiating a new cycle 1 NINLARO should not be taken with food. Food may of therapy interfere with the absorption of NINLARO, which • Absolute neutrophil count should be at least 1000/mm3 may lower levels of the medication in the blood and • Platelet count should be at least 75,000/mm3. Monitor possibly reduce effectiveness. platelet counts at least monthly during treatment • NINLARO should be taken on an empty stomach or at with NINLARO least 1 hour before or at least 2 hours after food • Nonhematologic toxicities should, at the healthcare • NINLARO should not be taken at the same time as provider’s discretion, generally be recovered dexamethasone because dexamethasone should be to patient’s baseline condition or grade 1 or lower taken with food • No body surface area dosing is required • NINLARO should be swallowed whole with water and should not be crushed, chewed, or opened • If a NINLARO dose is delayed or missed, the dose should be taken only if the next scheduled dose is at least 72 hours away — A double dose should not be taken to make up for the missed dose — If vomiting occurs after taking a dose, the patient should Communication is key not repeat the dose. The patient should resume dosing at the time of the next scheduled dose • There’s no such thing as overcommunicating • To verify comprehension, have patients repeat • Antiviral prophylaxis should be considered in information in their own words patients being treated with NINLARO to decrease the risk of herpes zoster reactivation Please see Important Safety Information on pages 20-21 and accompanying NINLARO (ixazomib) 6 full Prescribing Information. Storage1 Capsule warnings1 • NINLARO® (ixazomib) may be stored at room temperature. Do not store above 30°C (86°F). Do not freeze • Store capsules in original packaging until immediately prior to use Handling and disposal1 • NINLARO is cytotoxic. Capsules should not be opened, crushed, or chewed. Direct contact with the capsule contents should be avoided • NINLARO is available in single dose packs (1 pill) and complete monthly dose packs (3 pills) Capsule should Capsule should not be crushed not be chewed • Any unused medicinal product or waste material should be disposed of in accordance with local requirements Capsule should Capsule should not be Capsule breakage1 not be opened removed from original packaging until time • In case of capsule breakage, avoid of consumption direct contact of capsule contents with the skin or eyes. If skin contact occurs, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water Please see Important Safety Information on pages 20-21 and accompanying NINLARO (ixazomib) 8 full Prescribing Information. Nonhematologic ARs occurring in ≥5% of patients with a ≥5% difference between the NINLARO® (ixazomib) regimen* and the Rd regimen1* AR AR NINLARONINLARO regimen regimen (n=360) (n=360) Rd regimenRd regimen (n=360) (n=360) Di erenceDi erence † † † † * The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone. †Represents a pooling of preferred terms. Additional safety information1 • Serious ARs reported in ≥2% of patients included thrombocytopenia (2%) and diarrhea (2%) Please see Important Safety Information on pages 20-21 and accompanying NINLARO (ixazomib) 10 full Prescribing Information. Hematologic adverse events1 Discontinuation rates NINLARO® (ixazomib) Rd Discontinuation rates were comparable between the regimen* regimen* NINLARO® (ixazomib) and Rd regimens5* (n36) (n36) Discontinuation rates of the Dose n () n () entire regimen due to ARs tolerability Any grade rades 3-4 Any grade Grades 3-4 Thrombocytopenia 281 (78) 93 (26) 196 (4) 39 (11) 13% Neutropenia 24 (67) 93 (26) 239 (66) 107 (30) VS 80% of patients continued Represents pooled information from adverse event and laboratory data. at the starting dose of 11% NINLARO without dose with the NINLARO reduction and Rd regimens, respectively • For each AR, 1 or more of the 3 drugs were discontinued in ≤1% of patients in the NINLARO regimen1 • The median time on therapy for patients in the NINLARO arm was 17 cycles compared with 15 cycles for patients in the Rd arm6 • The most common ARs (≥20%) in the NINLARO regimen and greater than the Rd regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious ARs reported in ≥2% of patients included thrombocytopenia (2%) and diarrhea (2%)1 *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone. Please see Important Safety Information on pages 20-21 and accompanying NINLARO (ixazomib) 12 full Prescribing Information. Prepare patients for side effects Management of some ARs may and dosing concerns require modification of the 1 Concomitant medications may be given for prophylaxis NINLARO dose and/or management of symptoms7,8 NINLARO dose modification schedule Prophylaxis/ Condition symptomatic Consider* 4 mg Recommended starting dose GI toxicity: diarrhea Symptomatic Antidiarrheal (eg, loperamide) 3 mg First dose reduction GI toxicity: nausea/ Prophylaxis or Antiemetics, Recommended starting dose for patients with: vomiting symptomatic antinauseants • Moderate or severe hepatic impairment‡ § (eg, ondansetron, • Severe renal impairment metoclopramide) • End-stage renal disease reuiring dialysis 2.3 mg Viral infection: herpes Prophylaxis† or Antivirals† Second dose reduction zoster (reactivation) symptomatic If toxicities Rash Prophylaxis or Antihistamines Discontinuation continue symptomatic (eg, cetirizine) or corticosteroids Not actual capsule size. (oral or topical; eg, prednisone) • No dose adjustment is required for: * These medications and supportive therapies are examples of appropriate — Elderly patients 6 supportive care that were permitted in the phase 3 clinical trial. § †Patients treated in the NINLARO regimen who received antiviral prophylaxis
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