satralizumab

Absorption: 85% absorbed following SUBQ administration.

Distribution: Minimally distributed to extravascular tissues.

Metabolism/Excretion: Metabolized to small peptides through catabolic pathways.

Half-Life: 30 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active hepatitis B virus (HBV) infection;
Active or untreated latent tuberculosis (TB);
Active infection.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: cellulitis, pruritus, rash

EENT: nasopharyngitis

GI: gastritis, ↑liver enzymes, HBV reactivation, nausea

Hemat: thrombocytopenia, ↓fibrinogen, NEUTROPENIA

Local: injection site reactions

Metab: hypercholesterolemia, hypertriglyceridemia, weight gain

MS: ↑creatine kinase, arthralgia

Neuro: depression, fatigue, headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION (INCLUDING TB)

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to and ↑ risk of adverse reactions to live-virus vaccines; do not administer concurrently.

Route/Dosage ⬆ ⬇

SC (Adults ): 120 mg initially and then at Wk 2 and Wk 4; then 120 mg every 4 wk.

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 120 mg/mL

Assessment ⬆ ⬇

Assess for infection (fever, chills, constant cough, sore throat, nonhealing wound). Delay administration until infection has resolved.
Monitor for hypersensitivity reactions (rash, urticaria, anaphylaxis). Implement appropriate medical management if symptoms occur.
Vaccination with live or live-attenuated vaccines is not recommended during treatment. Administer all live or live-attenuated vaccines >4 wk and non-live vaccines >2 wk before starting treatment.

Lab Test Considerations:

Obtain screening for HBV before 1st dose. If negative surface antigen and positive HB core antibody or carriers of HBV, consult liver disease experts before and during treatment.
Obtain TB screening and test for latent infection. If active or positive TB without history of appropriate treatment, consult infectious disease experts before starting treatment.
Monitor liver enzymes and serum bilirubin before starting therapy. Monitor ALT and AST every 4 wk for first 3 mo, followed by every 3 mo for 1 yr, and thereafter as clinically necessary. If ALT/AST >5 times upper limit of normal (ULN) and any bilirubin ↑, permanently discontinue satralizumab. If ALT/AST >5 times ULN and no bilirubin ↑, interrupt therapy until ALT/AST return to normal range. Restart dose at 120 mg every 4 wk if <12 wk since last dose. If ≥12 wk since last dose, administer 120 mg every 2 wk for three doses (Wk 0, 2, and 4), followed by 120 mg every 4 wk. After restarting therapy, if ALT/AST and/or bilirubin ↑, permanently discontinue satralizumab.
Monitor neutrophil counts 4–8 wk after start of therapy and thereafter as clinically indicated. If ANC <1.0 × 10⁹/L and confirmed by repeat testing, hold dose until ANC >1.0 × 10⁹/L.
Monitor platelet count. May ↓ platelets.

Implementation ⬆ ⬇

Administer by a health care professional. After proper training, may be administered by patient/caregiver.
SC: Remove prefilled syringe from refrigeration 30 min before administering. Visually inspect solution for particulate matter and discoloration. Do not use if cloudy, discolored, or contains particles or if any part of syringe appears damaged. Administer full amount (1 mL) into the abdomen or thigh. Rotate site with each injection, and avoid moles; scars; or tender, bruised, red, or hard skin.
Recommended Dosage for Delayed or Missed Doses (reasons other than ↑ liver enzymes): If missed loading dose, administer 120 mg as soon as possible (do not wait until next planned dose). If 2nd loading dose is delayed or missed, administer as soon as possible and administer the 3rd (final) loading dose in 2 wk. If 3rd loading dose is delayed or missed, administer as soon as possible and administer the 1st maintenance dose in 4 wk. If last dose <8 wk, administer 120 mg as soon as possible. Reset dose for every 4 wk. If last dose 8–<12 wk, administer 120 mg every 2 wk for 2 doses (Wk 0 and 2), followed by 120 mg every 4 wk. If last dose >12 wk, administer 120 mg every 2 wk for 3 doses (Wk 0, 2, and 4), followed by 120 mg every 4 wk.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise to read Patient Information before starting therapy. Instruct patient/caregiver on proper administration education, injection technique, and syringe disposal, if applicable.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Advise patient to complete any required live or live-attenuated vaccinations >4 wk and for non-live vaccines >2 wk before starting therapy.
Advise patient to notify health care professional if signs or symptoms of liver problems (dark urine, tiredness, ↓ appetite, upset stomach or pain, light-colored stools, vomiting, yellow skin or eyes) occur.
Inform patient to adhere to all necessary laboratory testing.
Advise patient to notify health care professional if any signs and symptoms of an infection occur.
Inform patient about hypersensitivity reactions, including anaphylaxis, and to seek immediate medical attention if symptoms occur.
Rep: Advise women of reproductive potential if pregnancy is suspected or planned or if breastfeeding. Health care providers should register patients and encourage pregnant patients to register for the pregnancy exposure registry that monitors pregnancy outcomes by calling 1-833-277-9338.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇