TM Owner Takeda
Ninlaro 4mg Capsule
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Indications & Clinical Uses
- Ninlaro 4 mg capsules contain ixazomib, an oral proteasome inhibitor.
- It is indicated in combination with lenalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior line of therapy.
- Ninlaro is not recommended for use outside a controlled clinical trial in newly diagnosed patients or as maintenance therapy.
- It is taken once weekly, on days 1, 8 and 15 of a 28-day treatment cycle, together with the other two medicines in the combination, and treatment is prescribed and monitored by a haematologist or oncologist.
- Ninlaro's US FDA-approved manufacturer of record is Takeda Pharmaceuticals America, Inc.; content here follows this US prescribing information, as the EU-specific EPAR page could not be fetched this session.
Side Effects
- The most common side effects, each affecting 1 in 5 people or more, are low platelet counts (thrombocytopenia) and low white cell counts, diarrhoea, constipation, nausea and vomiting, peripheral neuropathy (numbness, tingling or pain, usually in the hands or feet), swelling of the hands, ankles or feet, skin rash, back pain and upper respiratory infections such as bronchitis.
- Platelet counts are checked monthly because of the risk of bruising or bleeding.
- Seek prompt medical attention for unusual bruising or bleeding, severe or persistent diarrhoea or vomiting, new numbness or pain in the hands or feet, yellowing of the skin or eyes, or a widespread skin rash with blistering, which can rarely be serious.
- There is no boxed warning on the current US label, but these effects are actively monitored throughout treatment with regular blood tests.
Precautions & Warnings
- Ninlaro requires monthly platelet count monitoring because of thrombocytopenia, and dose reduction or temporary interruption may be needed for low counts, severe diarrhoea, nausea, vomiting, peripheral neuropathy, skin reactions or liver test changes.
- Take each dose at least 1 hour before or 2 hours after food, at approximately the same time each week; swallow the capsule whole and never break, chew or open it.
- Ninlaro can cause liver problems, so liver function tests are checked periodically, and rarely serious skin reactions and a clotting disorder called thrombotic microangiopathy have been reported.
- It may cause harm to an unborn baby, so it must not be used in pregnancy; women who could become pregnant and men with partners who could become pregnant must use effective contraception during treatment and for a period afterwards, and breastfeeding is not recommended.
- Because it is given with lenalidomide, which itself carries additional pregnancy restrictions, patients are managed under the full combination regimen's safety requirements.
- Dose reduction is required for moderate-to-severe hepatic or severe renal impairment.
Avoid Interactions
- Avoid taking Ninlaro with strong CYP3A inducers, such as rifampin, carbamazepine, phenytoin and St John's Wort, since these substantially reduce ixazomib levels and could reduce its effectiveness.
- Caution is advised with strong CYP3A4 or CYP1A2 inhibitors, which may raise ixazomib exposure; your prescriber may adjust monitoring if these cannot be avoided.
- Because Ninlaro is given alongside lenalidomide and dexamethasone, all of the interaction precautions and monitoring for that full combination apply, including increased infection risk with dexamethasone and blood clot risk with lenalidomide.
- Tell your healthcare provider about every other prescription and over-the-counter medicine, herbal product and supplement you take before and during treatment, since many drugs are processed through the same liver enzyme pathways.
- Report any new medicine started by another prescriber while you are on Ninlaro.
References
Frequently Asked Questions
Ninlaro (ixazomib) 4 mg treats multiple myeloma in adults who have had at least one previous treatment, given together with lenalidomide and dexamethasone. It is an oral proteasome inhibitor prescribed and monitored by a cancer specialist throughout each 28-day treatment cycle.
Swallow one Ninlaro capsule whole, once weekly on days 1, 8 and 15 of each 28-day cycle, at least 1 hour before or 2 hours after food. Never break, chew or open the capsule, and take it alongside your prescribed lenalidomide and dexamethasone.
Very common effects include low platelet and white cell counts, diarrhoea, constipation, nausea, vomiting, nerve tingling or numbness (peripheral neuropathy), swelling, and rash. Platelets are checked monthly. Report unusual bruising, bleeding, severe diarrhoea, or new numbness to your care team promptly.
Avoid strong CYP3A inducers such as rifampin, carbamazepine, phenytoin and St John's Wort, which weaken Ninlaro's effect. Take it apart from food as directed, and tell your care team about every other medicine and supplement, since Ninlaro is always used with lenalidomide and dexamethasone.
No, the current US label for Ninlaro does not carry a boxed warning. However, monthly platelet counts are required throughout treatment, along with periodic liver function tests, because of the real risk of thrombocytopenia and, less often, liver problems developing during treatment.
No. Ninlaro may harm an unborn baby, so effective contraception is required during treatment and for a period afterwards for both patients and their partners, and breastfeeding is not recommended. This applies on top of lenalidomide's own strict pregnancy-prevention programme.
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