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NINLARO is a brand name for Ixazomib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NINLARO [ixazomib (as ixazomib citrate)] is indicated: • in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of NINLARO in children below 18…
Verbatim from this product's HC label. Tap a section to expand.
). • Avoid direct contact with capsule contents because NINLARO may be harmful by inhalation, ingestion, or skin absorption. 1 Dosing Considerations For patient monitoring and assessment prior to and during treatment with NINLARO in combination with lenalidomide and dexamethasone, see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests.
Geriatrics:
No dose adjustment of NINLARO is required for patients over 65 years of age (see 7 WARNINGS AND PRECAUTIONS).
Hepatic Impairment:
No dose adjustment of NINLARO is required for patients with mild hepatic impairment. For patients with moderate or severe hepatic impairment, a lower starting dose of 3 mg is recommended. 2 Special Populations, Hepatic Impairment and 10 CLINICAL PHARMACOLOGY).
Renal Impairment:
No dose adjustment of NINLARO is required for patients with mild or moderate renal impairment. For patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis, a lower starting dose of 3 mg is recommended.
2 Special Populations, Renal Impairment and 10 CLINICAL PHARMACOLOGY). 2 Recommended Dose and Dosage Adjustment NINLARO in combination with lenalidomide and dexamethasone The recommended starting dose of NINLARO is 4 mg (one capsule) administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle.
The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 through 21 of a 28-day treatment cycle. The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
NINLARO (as ixazomib c itrate) capsules Page 7 of 42 Unclassified / Non classifié For additional information regarding lenalidomide and dexamethasone, refer to their respective product monographs. Prior to initiating a new cycle of therapy: • Absolute neutrophil count should be ≥ 1,000/mm3 • Platelet count should be ≥ 75,000/mm3 • Non-hematologic toxicities should, at the health professional’s discretion, generally be recovered to patient’s baseline condition or ≤ Grade 1 Treatment should be continued until disease progression or unacceptable toxicity.
) and provide appropriate supportive care. Healthcare professionals should instruct patients and care givers that only one dose of NINLARO should be taken at a time, and only at the prescribed interval (one capsule, once a week, on days 1, 8, and 15 of every 28-day cycle).
The importance of carefully following all dosage instructions should be discussed with patients starting treatment. For management of a suspected drug overdose, contact your regional poison control centre. 3 mg, respectively, of ixazomib.
NINLARO capsules are supplied as a pack of 3 capsules packaged in PVC-Aluminum/Aluminum blisters sealed within the blister strip inside a wallet. Each blister contains one capsule. 3 mg Magnesium stearate, microcrystalline cellulose, and talc.
3 mg), red oxide (4 mg), titanium dioxide, yellow oxide (4 mg). The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. NINLARO (as ixazomib c itrate) capsules Page 12 of 42 Unclassified / Non classifié 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Herpes Zoster Herpes zoster was reported in 6% of patients in the NINLARO regimen and 3% of patients in the placebo regimen. Antiviral prophylaxis was allowed at the health professional’s discretion. Patients treated in the NINLARO regimen who received antiviral prophylaxis had a lower incidence (1%) of herpes zoster infection compared to patients who did not receive prophylaxis (10%).
Antiviral prophylaxis should be considered in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation. Peripheral Edema Peripheral edema has been reported in 27% and 21% of patients in the NINLARO and placebo regimens, respectively (see 8 ADVERSE REACTIONS).
Grade 3 peripheral edema was reported in 2% and 1% of patients in the NINLARO and placebo regimens, respectively. There were no Grade 4 or 5 events reported. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing for Grade 3 or 4 symptoms (see 4 DOSAGE AND ADMINISTRATION).
, Skin 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES ..............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 LIST OF TABLES ........................................................................................................................
3 LIST OF FIGURES ...................................................................................................................... 4 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................
5 1 INDICATIONS................................................................................................................ 1 Pediatrics ..........................................................................................................
2 Geriatrics .......................................................................................................... 5 2. CONTRAINDICATIONS ...................................................................................................
5 3. SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment .................................................... 1 Pregnant Women ........................................................................................ 2 Breast-feeding.............................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Dose Modifications The NINLARO dose reduction steps are presented in Table 2 and the dose modification guidelines are provided in Table 3. 3 mg *Recommended starting dose of 3 mg in patients with moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease requiring dialysis.
An alternating dose modification approach is recommended for NINLARO and lenalidomide for overlapping toxicities of thrombocytopenia, neutropenia, and rash as described in Table 3. Refer to the lenalidomide product monograph for dose modification guidelines if dose modification is needed for lenalidomide.
Table 1 Dosing Schedule:
NINLARO taken with Lenalidomide and Dexamethasone Take medicine 28-Day Cycle (a 4-week cycle) Week 1 Week 2 Week 3 Week 4 Day 1 Days 2-7 Day 8 Days 9-14 Day 15 Days 16-21 Day 22 Days 23-28 NINLARO Lenalidomide Daily Daily Daily Dexamethasone NINLARO (as ixazomib c itrate) capsules Page 8 of 42 Unclassified / Non classifié Table 3 Dose Modifications Guidelines for NINLARO in Combination with Lenalidomide and Dexamethasone Hematological Toxicities Recommended Actions Thrombocytopenia (Platelet Count) Platelet count < 30,000/mm3 • Withhold NINLARO and lenalidomide until platelet count ≥ 30,000/mm3.
• Following recovery, resume lenalidomide at the next lower dose according to its product monograph and resume NINLARO at its most recent dose. • If platelet count falls to < 30,000/mm3 again, withhold NINLARO and lenalidomide until platelet count ≥ 30,000/mm3.
* Neutropenia (Absolute Neutrophil Count) Absolute neutrophil count less than 500/mm3 • Withhold NINLARO and lenalidomide until absolute neutrophil count is at least 500/mm3. Consider adding G-CSF as per clinical guidelines. • Following recovery, resume lenalidomide at the next lower dose according to its product monograph and resume NINLARO at its most recent dose.
• If absolute neutrophil count falls to less than 500/mm3 again, withhold NINLARO and lenalidomide until absolute neutrophil count is at least 500/mm3. * NINLARO (as ixazomib c itrate) capsules Page 9 of 42 Unclassified / Non classifié Table 3 Dose Modifications Guidelines for NINLARO in Combination with Lenalidomide and Dexamethasone Non-Hematological Toxicities Recommended Actions Rash Grade† 2 or 3 Rash • Withhold lenalidomide until rash recovers to ≤ Grade 1.
• Following recovery, refer to the lenalidomide product monograph for dose modification guidelines. • If Grade 2 or 3 rash occurs again, withhold NINLARO and lenalidomide until rash recovers to ≤ Grade 1. • Following recovery, resume NINLARO at the next lower dose and refer to the lenalidomide product monograph for dose modification guidelines.
* Grade 4 Rash • Discontinue the NINLARO regimen. Peripheral Neuropathy Grade 1 Peripheral Neuropathy with Pain or Grade 2 Peripheral Neuropathy • Withhold NINLARO until peripheral neuropathy recovers to ≤ Grade 1 without pain or patient's baseline.
• Following recovery, resume NINLARO at its most recent dose. Grade 2 Peripheral Neuropathy with Pain or Grade 3 Peripheral Neuropathy • Withhold NINLARO. Toxicities should, at the health professional’s discretion, generally recover to patient’s baseline condition or ≤ Grade 1 prior to resuming NINLARO.
• Following recovery, resume NINLARO at the next lower […]
Driving and Operating Machinery No studies on the effects on the ability to drive or use machines have been performed. Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. Gastrointestinal Diarrhea, vomiting, nausea and constipation have been reported with NINLARO (see 8 ADVERSE REACTIONS).
Medical management included dose modification, use of antidiarrheal and antiemetic medications, and supportive care. Adjust dosing for Grade 3 or 4 symptoms (see 4 DOSAGE AND ADMINISTRATION). Hematologic Thrombocytopenia Thrombocytopenia has been reported with NINLARO (see 8 ADVERSE REACTIONS) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle.
Thrombocytopenia (combined preferred terms of thrombocytopenia and platelet count decreased) was reported as an adverse event in 37% of patients in the NINLARO regimen and 18% in the placebo regimen. The difference in frequency was across all grades, including Grade 3 and Grade 4 thrombocytopenia (21% and 10% of patients in the NINLARO and placebo regimens, respectively).
Two percent of patients in both the NINLARO regimen and the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment. Thrombocytopenia did not result in an increase in hemorrhagic events or platelet transfusions. Platelet counts should be monitored at least monthly during NINLARO treatment.
More NINLARO (as ixazomib c itrate) capsules Page 13 of 42 Unclassified / Non classifié frequent monitoring should be considered during the first three cycles. Thrombocytopenia should be managed with dose modifications (see 4 DOSAGE AND ADMINISTRATION) and platelet transfusions as per standard medical guidelines.
Thrombotic Microangiopathy Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), have been reported in patients who received NINLARO. Some of these events have been fatal.
Monitor for signs and symptoms of TTP/HUS. Withhold NINLARO if TTP/HUS is suspected. If TTP/HUS is confirmed, discontinue NINLARO. The safety of reinitiating NINLARO therapy in patients previously experiencing TTP/HUS is not known. Hepatic/Biliary/Pancreatic Hepatic Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO.
Events of liver impairment have been reported (10% in the NINLARO regimen and 9% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms (see 4 DOSAGE AND ADMINISTRATION). Monitoring and Laboratory Tests Platelet counts should be monitored at least monthly during NINLARO treatment.
More frequent monitoring should be considered during the first three cycles. Monitor hepatic enzymes regularly when NINLARO is administered in combination with lenalidomide and dexamethasone. Neurologic Peripheral neuropathy Peripheral neuropathies have been reported with NINLARO (see 8 ADVERSE REACTIONS).
The majority of peripheral neuropathy adverse reactions were Grade 1 (18% and 16% in the NINLARO and placebo […]
3 Pediatrics .................................................................................................... 4 Geriatrics .................................................................................................... 5 Hepatic Impairment.....................................................................................
6 Renal Impairment ........................................................................................ 34 LIST OF TABLES Table 1 Dosing […]