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.

Managing Adverse Events

NINLARO + Rd adverse events were generally Grade 1 or 2 and were manageable with supportive care1

For overlapping toxicities (thrombocytopenia, neutropenia and rash), the first dose reduction step is to reduce lenalidomide

For full dose modification recommendations please refer to the NINLARO Summary of Product Characteristics

Myelosuppression
  • Platelet counts should be monitored at least monthly during treatment with NINLARO - more frequent monitoring should be considered during the first three cycles as per the lenalidomide SmPC1,3
  • Manage thrombocytopenia and neutropenia with dose modification and platelet transfusions or G-CSF respectively, as per standard medical guidelines1
  • An alternating dose modification approach is recommended for NINLARO and lenalidomide for overlapping toxicities of thrombocytopenia and neutropenia
    Adverse Event Recommended Action1
    Thrombocytopenia (platelet count <30,000/mm3)

    and/or

    Neutropenia (absolute neutrophil count < 500/mm3)
    • Withhold NINLARO and lenalidomide until platelet or absolute neutrophil counts are ≥30,000/mm3 or ≥ 500/mm3, respectively
    • Following recovery, resume lenalidomide at the next lower dose according to its SmPC and resume NINLARO at the most recent dose
    • If platelet or absolute neutrophil counts drops again to <30,000/mm3 or < 500/mm3 respectively, withhold NINLARO and lenalidomide until recovery
    • Following recovery, resume NINLARO at the next lower dose, and resume lenalidomide at the most recent dose*

    * For additional occurrences, alternate dose modification of lenalidomide and NINLARO

Peripheral neuropathy
  • Patients on NINLARO should be monitored for symptoms of neuropathy, such as a burning sensation, hyperaesthesia, hypoaesthesia, paraesthesia, discomfort, neuropathic pain or weakness1
  • Patients experiencing new or worsening PN may require dose modification (see table below)1
  • Withhold treatment or adjust dosing for Grade 1 to 3 symptoms1
  • Discontinue treatment for Grade 4 symptoms1
    Adverse Event Recommended Action1
    Grade 1 PN with pain
    Grade 2 PN
    • Withhold NINLARO until PN recovers to ≤Grade 1 without pain or patient's baseline condition
    • Following recovery, resume NINLARO at the most recent dose
    Grade 2 PN with pain
    Grade 3 PN
    • Withhold NINLARO - toxicities should, at the physician's discretion, generally recover to patient's baseline condition or ≤Grade 1 prior to resuming NINLARO
    • Following recovery, resume NINLARO at the next lower dose
    Grade 4 PN
    • Discontinue treatment regimen
Rash
  • Rash has been most commonly characterised as maculo-papular or macular and is most commonly reported within the first 3 cycles of therapy1,5
  • Symptomatic measures such as antihistamines or corticosteroids (oral or topical) have been used successfully to manage rash and have been used prophylactically in subsequent cycles during NINLARO clinical studies6
  • The use of a topical, IV or oral steroid (e.g. prednisolone ≤10 mg per day or equivalent) was permitted within the TOURMALINE‑MM1 study6
  • Manage rash with supportive care and/or with dose modification if Grade 2 or 31
  • Discontinue treatment if Grade 4 symptoms1
    Adverse Event Recommended Action1
    Grade 2 or 3 rash
    • Withhold lenalidomide until rash recovers to ≤Grade 1
    • Following recovery, resume lenalidomide at the next lower dose according to its SmPC
    • 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 resume lenalidomide at its most recent dose
    Grade 4
    • Discontinue treatment regimen

    Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03

    For additional occurrences, alternate dose modification of lenalidomide and NINLARO

Gastrointestinal toxicities
  • Reversible diarrhoea, nausea, vomiting, decreased appetite and constipation have been reported in clinical studies1,2
  • Patients should be monitored for gastrointestinal toxicity and should be given appropriate supportive care1,2
  • Standard anti-emetics including 5‑HT 3 antagonists are recommended according to clinical practice for emesis if it occurs once treatment is initiated - prophylactic anti-emetics may also be considered at the physician's discretion6
  • Dexamethasone should not be administered as an anti-emetic6
  • Prophylactic antidiarrhoeals are not recommended; however diarrhoea should be managed according to standard clinical practice, including the administration of antidiarrhoeals once infectious causes are excluded6
  • Fluid deficits should be corrected before initiation of NINLARO and as needed during treatment to avoid dehydration6
    Adverse Event Recommended Action1
    Grade 3 or 4 gastrointestinal toxicities
    • Withhold NINLARO - toxicities should, at the physician's discretion, generally recover to patient's baseline condition or ≤Grade 1 prior to resuming NINLARO
    • If attributable to NINLARO, resume NINLARO at the next lower dose following recovery
  • In the case of severe gastrointestinal events, monitoring of serum potassium level is recommended1
  • For lenalidomide-related toxicity, refer to the lenalidomide SmPC for dose adjustments
Other non-haematological toxicities
Adverse Event Recommended Action1
Other Grade 3 or 4 non haematological toxicities
  • Withhold NINLARO - toxicities should, at the physician's discretion, generally recover to patient's baseline condition or ≤Grade 1 prior to resuming NINLARO
  • If attributable to NINLARO, resume NINLARO at the next lower dose following recovery
  • For lenalidomide- and dexamethasone-related toxicities, refer to the lenalidomide or dexamethasone SmPCs for dose adjustments

NINLARO Patient Support Programme (PSP)

This NINLARO Patient Support Programme (PSP) has been designed to help patients familiarise themselves with the NINLARO based triplet regimen. The programme is intended for patients that are currently receiving or are about to initiate treatment with the NINLARO regimen.

To download a copy of the booklet, which provides further information on the programme for Healthcare Professional click here

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