VA CFU Criteria Formulary Advisor Reference
← Back to Drug List

TERIFLUNOMIDE TAB,ORAL

Generic Name
TERIFLUNOMIDE TAB
Brand Names
AUBAGIO
Drug Class
MUSCULOSKELETAL AGENTS,OTHER
Formulary Status
PA-F
Copay Tier
2
Last Updated
2023-03-16

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

Source Documents

Download CFU PDF