TABLE 2.
| DMT | Route | Select common and/or serious adverse reactions | Monitoring |
|---|---|---|---|
| Natalizumab (Tysabri, biosimilar available)a | I.V. | Headache, fatigue, arthralgia, UTI, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, and rash | Prior to initiation: Brain MRI, CBC w/diff, LFTs, and anti-JCV antibody with index |
| During therapy: CBC w/diff and LFTs every 6 months and anti-JCV antibody with index every 3 to 6 months | |||
| Anti-CD20 monoclonal antibodies: | Upper and lower respiratory tract infections, skin infections, and infusion reactions (pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis) | Prior to initiation: Screening for hepatitis B virus, IGRA testing (TB screening), VZV-IgG testing, testing for serum immunoglobulins, LFTs, CBC w/diff, and lymphocyte subset panel (to obtain baseline CD19+ cell count) | |
| Rituximab (Rituxan and biosimilars)∗ | I.V. | During therapy: CBC w/diff, LFTs, and lymphocyte subset panel (CD19+) every 6 months (prior to infusion); MRI brain annually; IgG levels at least annually; standard cancer screenings | |
| Ocrelizumab (Ocrevus)a,b | I.V. | ||
| Ublituximab (Briumvi)a | I.V. | ||
| Ofatumumab (Kesimpta)a | Subcutaneous | Upper respiratory tract infections, headache, systemic injection-related reactions, and local injection site reactions | |
| Alemtuzumab (Lemtrada)c | I.V. | Rash, headache, pyrexia, nasopharyngitis, nausea, vomiting, UTI, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, extremity pain, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and infusion reactions (anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia, hypertension, headache, pyrexia, rash, fatigue, dysgeusia, dyspepsia, dizziness, pain, urticaria, and nausea) | Prior to initiation: CBC w/diff, serum creatinine, urine protein-to-creatinine ratio, UA with urine cell counts, TSH, LFTs, VZV IgG, TB screening, and skin exam |
| During therapy: CBC w/diff, serum creatinine levels, and UA with urine cell counts monthly; TSH every 3 months; LFTs periodically; and skin exam annually, all continuing until 48 months after last treatment course. Standard cancer screenings. | |||
| Cladribine (Mavenclad)d | P.O. | Upper respiratory tract infection, headache, lymphopenia, and infections (particularly herpes zoster) | Prior to initiation: Brain MRI; standard cancer screenings; pregnancy testing; CBC w/diff; LFTs; and HIV, hepatitis B and C, TB, and VZV-IgG testing |
| During therapy: CBC w/diff before each treatment course and at months 2 and 6 after the start of each treatment course. If lymphocytes ≤200 cells/mcL, place patient on herpes prophylaxis and repeat labs monthly. |
Abbreviations: CBC, complete blood cell count; DMT, disease-modifying therapy; IgG, immunoglobulin G; IGRA, interferon-gamma release assay; JCV, John Cunningham virus; LFTs, liver function tests; TB, tuberculosis; TSH, thyroid-stimulating hormone; UA, urinalysis; UTI, urinary tract infection; VZV, varicella zoster virus; w/diff, with differential.
Off-label for treatment of MS.
Indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Indicated for the treatment of primary progressive MS in adults.
Indicated for the treatment of relapsing forms of MS, to include relapsing-remitting disease and active secondary progressive disease, in adults who have had an inadequate response to two or more drugs indicated for the treatment of MS. Not recommended for use in clinically isolated syndrome.
Indicated for the treatment of relapsing forms of MS, to include relapsing-remitting disease and active secondary progressive disease, in adults who have had an inadequate response to, or are unable to tolerate, an alternative drug indicated for the treatment of MS. Not recommended for use in clinically isolated syndrome.
Note: This is not a complete list of all prescribing and monitoring considerations. Providers should refer to appropriate guidelines and drug package inserts.