• Patients with relapsing forms of multiple sclerosis who have had an inadequate response to 2 drugs.

Contraindicated in:

• Hypersensitivity
• Hepatic impairment (including ALT or AST 2x ULN)
• Autoimmune hepatitis or other autoimmune condition involving the liver
• Pedi: Children <17 yr (due to risks of hepatic injury and immune-mediated disorders).

Use Cautiously in:

• Current or a history of depression
• OB: Safety not established
• Lactation: Weigh benefits of breastfeeding against possible adverse effects.

CNS: SUICIDAL IDEATION/BEHAVIORS, depression.

Derm: rash, acne, dermatitis, eczema, psoriasis.

EENT: nasopharyngitis, rhinitis.

GI: AUTOIMMUNE HEPATITIS, HEPATOTOXICITY, colitis, hyperbilirubinemia, ↑ liver enzymes, oropharyngeal pain.

Hemat: anemia, lymphadenopathy.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA), INFECTIONS (INCLUDING URINARY TRACT INFECTIONS, UPPER RESPIRATORY TRACT INFECTIONS, VIRAL INFECTIONS, AND TUBERCULOSIS), fever.

Drug-Drug:

• Concurrent use of hepatotoxic drugs can ↑ risk of hepatotoxicity.
• May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.

Drug-Natural Products:

• Concurrent use with hepatotoxic herbal products can ↑ risk of hepatotoxicity.

• Solution for subcutaneous injection (in prefilled syringe or prefilled autoinjector): 150 mg/mL;

• SC (Adults): 150 mg once monthly.

Zinbryta

• Binds specifically to the CD25 subunit of the interleukin-2 (IL-2) receptor on activated lymphocytes, preventing further activation of lymphocytes.

• Fewer exacerbations of relapsing multiple sclerosis and fewer lesions.

Therapeutic Classification: Immunosuppressant agents

Pharmacologic Classification: interleukin antagonists, monoclonal antibodies

Absorption: 90% absorbed following subcut administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Degraded by proteolytic enzymes located throughout the body.

Half-life: 21 days.

(blood levels)

• Instruct patient on proper technique, storage and disposal of equipment. Administer missed doses as soon as possible but no >2 wks late. After 2 wks, omit missed dose and take next dose at scheduled time; do not double doses. Advise patient to read Medication Guide and Instructions for Use before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional immediately if signs and symptoms of hepatotoxicity (nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, yellowing of skin or whites of eyes, dark urine), hypersensitivity reactions, infections, skin reactions (rash, skin irritation), lymphadenopathy (tender, swollen, painful lymph nodes), or colitis (fever, stomach pain, blood in stools, persistent diarrhea) occur.
• Advise patient and family to notify health care professional if behavioral changes, thoughts about suicide or dying, attempts to commit suicide; new or worse depression; feeling sad or crying spells, sleeping a lot more or a lot less than usual, feeling hopeless or helpless, irritability, anger, aggressive, trouble paying attention, frequently tired or sleepy, or other unusual changes in behavior or mood occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Instruct patient not to receive any vaccinations and to avoid contact with persons receiving oral polio vaccine during and for up to 4 mo after discontinuation of therapy without advice of health care professional.
• Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize the importance of monthly lab tests during and for 6 mo following therapy.
• Advise patient to carry Zinbryta Patient Wallet Card at all times and show care to other treating health care professionals.

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