DIMETHYL FUMARATE CAP,EC
Clinical Criteria Summary
Administration & Dosing
- IV infusion daily for 5 days then 1 year later, IV infusion daily for 3 days
- Repeat 3-day courses can be considered if clinically indicated and if at least 12 months after last dose
- Typical pre-medication: high dose corticosteroid as methylprednisolone 1000mg immediately prior to first alemtuzumab dose and for the first 3 days of each treatment course
Monitoring & Laboratory Requirements
- Baseline: HIV, VZV, TB, HBV, HCV, CBC w/ diff, CMP, UA w/ cell counts and adult onset Still's disease, thyroid function tests, autoimmune encephalitis, and acquired hemophilia
- Routine: CBC w/ diff, CMP, TSH, LFT, and UA
- Has a REMS program which also provides lab and imaging frequency guidance
Contraindications & Precautions
- Delay treatment if active skin infection
- Instruct patients to avoid potential sources of Listeria and monocytegenes VZV antibodies
- Give antivirals for herpes prophylaxis starting the first day of treatment until 2 months or CD4+ lymphocyte count is > 200 cells/microliter
Adverse Events
- Serious: Secondary autoimmune diseases (including autoimmune hepatitis, thyroid disorders, thrombotic thrombocytopenic purpura, hemophagocytic lymphohistiocytosis, protein, thyroid infusion reactions, stroke or cervicocephallic arterial dissection, malignancy, PML)
- Common: rash, headache, pyrexia, nasopharyngitis, nausea/vomiting, minor infections, fatigue, insomnia, urticaria, pruritus, thyroid disorders, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pian, flushing
Pregnancy & Lactation
- Avoid if pregnant
- Use contraception during and for 4 months after treatment course
- Avoid breastfeeding during treatment and at least 3 months after last dose
Washout & Switching Considerations
- An appropriate washout time from previous DMT is unknown
- The risks of a longer washout period should be weighed against the risks of another relapse
- Additive immunosuppression should be considered
- If switching from alemtuzumab to another DMT, lymphocyte counts can help assess magnitude of immunosuppression and additive risks