Presentation: Ixazomib 2.3 mg, 3 mg and 4 mg hard capsules. Indication: NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Dosage and administration: Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma. As NINLARO is administered in combination with lenalidomide and dexamethasone, refer to their SmPCs for further information. Recommended starting doses: NINLARO 4 mg (one capsule) administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle at least 1 hour before or at least 2 hours after food; lenalidomide 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle; dexamethasone 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle. Prior to initiating a new cycle of therapy, absolute neutrophil count should be ≥ 1,000/mm³, platelet count should be ≥ 75,000/mm³, non-haematologic toxicities should, at the physician’s discretion, generally be recovered to patient’s baseline condition or ≤ Grade 1. Treatment should be continued until disease progression or unacceptable toxicity. Treatment with NINLARO in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit risk assessment, as the data on the tolerability and toxicity beyond 24 cycles are limited. Antiviral prophylaxis should be considered in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation. Thromboprophylaxis is recommended in patients being treated with NINLARO in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient’s underlying risks and clinical status. Elderly: No dose adjustment is necessary in patients over 65 years of age. Renal impairment: Mild or moderate renal impairment, no dose adjustment is necessary. Reduced 3 mg starting dose recommended in severe renal impairment or end-stage renal disease requiring dialysis. Hepatic impairment: Mild hepatic impairment, no dose adjustment is necessary. Reduced 3 mg starting dose recommended in moderate or severe hepatic impairment. Paediatric population: No data are available. Overdose: NINLARO overdose of 12 mg (taken at one time) has resulted in serious adverse events, such as severe nausea, aspiration pneumonia, multiple organ failure and death. There is no known specific antidote for NINLARO overdose. The importance of carefully following all dosage instructions should be discussed with patients starting treatment. Contraindications: Hypersensitivity to the active substance or to its excipients. Warnings and precautions: Thrombocytopenia: Thrombocytopenia has been reported with NINLARO 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 did not result in an increase in haemorrhagic events or platelet transfusions. Platelet counts should be monitored at least monthly during NINLARO treatment. Thrombocytopenia can be managed with dose modifications and platelet transfusions as per standard medical guidelines. Gastrointestinal toxicities: Diarrhoea, constipation, nausea and vomiting have been reported with NINLARO, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care. The dose should be adjusted for severe (Grade 3–4) symptoms. Peripheral neuropathy: Peripheral neuropathy has been reported with NINLARO. Patients should be monitored for symptoms of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification. Peripheral oedema: Peripheral oedema has been reported with NINLARO. Patients should be evaluated for underlying causes and provided supportive care, as necessary. The dose of dexamethasone should be adjusted per its SmPC or NINLARO for Grade 3 or 4 symptoms. Cutaneous reactions: Rash has been reported with NINLARO. Rash should be managed with supportive care or with dose modification if Grade 2 or higher. Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, have also been rarely reported in association with NINLARO treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, NINLARO should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patient has developed a serious reaction such as SJS or TEN with the use of NINLARO, treatment with NINLARO must not be restarted in this patient at any time. Thrombotic microangiopathy (TMA): Cases of TMA, including thrombotic thrombocytopenic purpura/haemolytic uremic syndrome (TTP/HUS) have been reported in patients who received NINLARO. Some of these have been fatal. Signs and symptoms of TMA should be monitored for and NINLARO stopped if diagnosis is suspected. 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 dose should be adjusted for Grade 3 or 4 symptoms. Pregnancy: Women should avoid becoming pregnant while being treated with NINLARO. Posterior reversible encephalopathy syndrome (PRES): PRES has occurred in patients receiving NINLARO. In patients developing PRES, discontinue NINLARO. Interactions: Co-administration of strong CYP3A inducers with NINLARO is not recommended. No dose modification is required for NINLARO with co-administration of strong CYP3A inhibitors or strong CYP1A2 inhibitors. Fertility, pregnancy and lactation: As NINLARO is administered in combination with lenalidomide and dexamethasone, refer to their SmPCs for further information on fertility, pregnancy and lactation. Women should avoid becoming pregnant while being treated with NINLARO. Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Women using oral hormonal contraceptives should additionally use a barrier method of contraception. No data from use in pregnant women. Not recommended during pregnancy. Unknown whether NINLARO or its metabolites are excreted in human milk, a risk to newborns/infants cannot be excluded; therefore, breast feeding should be discontinued. No human fertility studies have been conducted. Effects on ability to drive and use machines: NINLARO has minor influence on the ability to drive or use machines. Fatigue and dizziness have been observed in clinical trials. Patients should be advised not to drive or operate machines if they experience any of these symptoms. Undesirable effects: Very common (≥1/10) (all grades): Upper respiratory tract infection, bronchitis, thrombocytopenia, neutropenia, peripheral neuropathies, diarrhoea, constipation, nausea, vomiting, rash, back pain, oedema peripheral, eye disorders, arthralgia and pyrexia. Common (≥1/100 to <1/10) (all grades): Herpes zoster. Grade 3 adverse reactions: Very common (≥1/10): Thrombocytopenia and neutropenia. Common (≥1/100 to <1/10): Upper respiratory tract infection, bronchitis, herpes zoster, peripheral neuropathies, diarrhoea, nausea, rash, oedema peripheral, hypokalaemia and arthralgia.   Uncommon (≥ 1/1 000 to < 1/100): Constipation, vomiting, back pain and pyrexia. Rare (≥ 1/10 000 to < 1/1 000): TTP, tumour lysis syndrome, posterior reversible encephalopathy disorders, transverse myelitis, SJS, acute febrile neutrophilic dermatosis and angioedema. Very rare (< 1/10 000): Anaphylactic reaction. Grade 4 adverse reactions: Common (≥1/100 to <1/10): Thrombocytopenia, neutropenia and hypokalaemia. Rare (≥ 1/10 000 to < 1/1 000):  Thrombotic microangiopathy, TTP, tumour lysis syndrome, posterior reversible encephalopathy disorders and TEN. Very rare (< 1/10 000): Anaphylactic reaction. Serious adverse reactions: Serious adverse reactions reported in ≥2% of patients included diarrhoea (3%), thrombocytopenia (2%) and bronchitis (2%). Fungal and viral pneumonia resulting in a fatal outcome were rarely reported. Refer to the SmPC for details on full side effect profile and interactions. Legal classification: POM. Marketing authorisation (MA) numbers: EU/1/16/1094/001, EU/1/16/1094/002, EU/1/16/1094/003. Name and address of MA holder: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark. Additional information is available on request at: medinfoEMEA@takeda.com. PI approval code: pi-04103. Date of preparation: May 2026.