This section is intended for UK healthcare professionals. If you are a member of the public click here. If you have been prescribed Ninlaro click here.

Before prescribing NINLARO

Therapeutic indication1

  • NINLARO (ixazomib capsules) in combination with lenalidomide and dexamethasone (Rd) is indicated for the treatment of adult patients with MM who have received at least one prior therapy

Contraindications1

  • Hypersensitivity to the active substance or to any of the excipients listed below:

NINLARO 4 mg capsule

NINLARO 4mg capsule
  • Microcrystalline cellulose
  • Magnesium stearate
  • Talc
  • Gelatin
  • Titanium dioxide (E171)
  • Yellow iron oxide (E172)
  • Red iron oxide (E172)
  • Shellac
  • Propylene glycol
  • Potassium hydroxide
  • Black iron oxide (E172)

NINLARO 3 mg capsule

NINLARO 3mg capsule
  • Microcrystalline cellulose
  • Magnesium stearate
  • Talc
  • Gelatin
  • Titanium dioxide (E171)
  • Black iron oxide (E172)
  • Shellac
  • Propylene glycol
  • Potassium hydroxide

NINLARO 2.3 mg capsule

NINLARO 2.3mg capsule
  • Microcrystalline cellulose
  • Magnesium stearate
  • Talc
  • Gelatin
  • Titanium dioxide (E171)
  • Red iron oxide (E172)
  • Shellac
  • Propylene glycol
  • Potassium hydroxide
  • Black iron oxide (E172)
  • As NINLARO is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional contraindications

Special warnings and precautions for use1

Thrombocytopenia

Thrombocytopenia has been reported with NINLARO, with platelet nadirs typically occurring between days 14 and 21 of each 28‑day cycle and recovery to baseline by the start of the next cycle (click here for guidance)

Gastrointestinal toxicities

Diarrhoea, constipation, nausea and vomiting have been reported with NINLARO, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care (click here for guidance)

Peripheral neuropathy

Peripheral neuropathy has been reported with NINLARO. Patient should be monitored for symptoms of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification (click here for guidance)

Peripheral oedema

Peripheral oedema has been reported with NINLARO. Patient should be evaluated for underlying causes and provide supportive care, as necessary. The dose of dexamethasone should be adjusted per its prescribing information or NINLARO for Grade 3 or 4 symptoms ( click here for guidance)

Cutaneous reactions/rash

Rash has been reported with NINLARO. Rash should be managed with supportive care or with dose modification (click here for guidance)

Hepatotoxicity

Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with NINLARO. Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms (click here for guidance)

Pregnancy

Women should avoid becoming pregnant while being treated with NINLARO. Male and female patients who are able to have children must use effective contraceptive measures while taking NINLARO and for 90 days after stopping treatment. Women using hormonal contraceptives should additionally use a barrier method of contraception

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES has occurred in patients receiving NINLARO. PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, altered consciousness and visual disturbances. Brain imaging, preferably Magnetic Resonance Imaging, is used to confirm the diagnosis. In patients developing PRES, discontinue NINLARO

Strong CYP3A inducers

Strong inducers may reduce the efficacy of NINLARO, therefore the concomitant use of strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin and St. John's Wort (hypericum perforatum) should be avoided. Closely monitor patients for disease control if co-administration with a strong CYP3A inducer cannot be avoided

  • As NINLARO is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional special warnings and precautions for use

Patient support

Takeda Oncology has developed a range of information and support tools designed for patients prescribed NINLARO

Click here to find out more about the support offered to NINLARO patients

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