crovalimab

Contraindicated in:

Hypersensitivity;
Unresolved serious Neisseria meninigitidis infection;
Lactation: Lactation.

Use Cautiously in:

Switching to/from another C5 inhibitor (e.g., eculizumab, ravulizumab) (↑ risk of hypersensitivity reactions);
Patients not vaccinated against Neisseria meninigitidis (unless risk of delaying treatment outweighs risks of developing a meningococcal infection) (vaccinate ≥2 wk prior to 1st dose);
Systemic infection;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Children <13 yr or <40 kg (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: peripheral edema

Derm: rash

GI: diarrhea, nausea

Metab: hyperuricemia

MS: arthralgia

Neuro: headache, fatigue

Misc: infusion-related reactions, Haemophilus influenzae infection, INJECTION-RELATED REACTIONS, MENINGOCOCCAL INFECTIONS, Neisseria gonorrhoeae infection, Streptococcus pneumoniae infection

Interactions ⬆ ⬇

Drug-drug:

Switching to/from eculizumab or ravulizumab may ↑ risk of serious hypersensitivity reactions; wait ≥5.5 half-lives before switching from/to crovalimab.

Availability ⬆ ⬇

Solution for injection: 170 mg/mL

Route/Dosage ⬆ ⬇

IV SC (Adults and Children ≥13 yr and ≥100 kg): 1500 mg IV on Day 1; then 340 mg SUBQ on Days 2, 8, 15, and 22; then 1020 mg SUBQ every 4 wk starting on Day 29.
IV SC (Adults and Children ≥13 yr and ≥40–<100 kg): 1000 mg IV on Day 1; then 340 mg SUBQ on Days 2, 8, 15, and 22; then 680 mg SUBQ every 4 wk starting on Day 29.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Monoclonal antibody that binds to complement protein C5. This binding inhibits complement activation, a necessary step in the initiation of hemolysis due to paroxysmal nocturnal hemoglobinuria.

Therapeutic effects:

Decreased hemolysis associated with paroxysmal nocturnal hemoglobinuria.

Classifications ⬆ ⬇

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: complement.inhibitors, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: 83% absorbed following SUBQ administration. IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Catabolized into small peptides and amino acids.

Half-Life: 53.1 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown
SUBQ	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
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.
Instruct patient to carry the Patient Safety Card at all times during and for 11 mo following therapy.
Instruct patient to obtain required meningococcal vaccine ≥2 wk prior to therapy per guidelines and to notify health care professional immediately for signs of infection (headache with nausea, vomiting, or stiff neck or back; fever≥103°F; rash; confusion; muscle aches with flu-like symptoms; eye sensitive to light). Inform patient that vaccination does not eliminate risk of meningococcal infection, despite development of antibodies.
Inform patients that crovalimab ↑ risk of infection. Advise patient to obtain required Streptococcus pneumoniae and Haemophilus influenzae type b vaccines per age and current guidelines and to notify health care professional of any signs and symptoms of infection.
Advise patient to notify health care professional immediately if infusion, injection (injection site pain, redness, headache, muscle pain), or hypersensitivity reactions (rash, itching, joint pain, numbness and tingling in hands or feet) occur.
Inform patient that hemolysis due to paroxysmal nocturnal hemoglobinuria may occur after discontinuing crovalimab and to notify a health care professional if signs and symptoms (fatigue, hemoglobinuria, abdominal pain, dyspnea, pain and swelling in extremities, stroke, erectile dysfunction) occur.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected. Advise women to avoid breastfeeding during therapy and for 9 mo after final dose.

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Indications ⬇

Contraind./Precautions ⬆ ⬇