sutimlimab (Rx)

Brand and Other Names:sutimlimab-jome, Enjaymo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg/mL (22 mL/single-dose vial)

Cold Agglutinin Disease

Indicated to decrease need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD)

39 to <75 kg: 6500 mg IV weekly for first 2 weeks, then q2Weeks thereafter

≥75 kg: 7500 mg IV weekly for first 2 weeks, then q2Weeks thereafter

Administer at or within 2 days of scheduled dose

Dosage Modifications

Renal impairment

  • Mild to moderate (eGFR 30-89 mL/min/1.73 m2): No dosage adjustment necessary
  • Severe:: Pharmacokinetics of sutimlimab are unknown

Dosing Considerations

Before initiating

Vaccinate against encapsulated bacteria ≥2 weeks before initiating therapy according to current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with persistent complement deficiencies

If urgent therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible

Safety and efficacy not established

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Adverse Effects

>10%

Respiratory tract infection (25%)

Viral infection (13%)

Diarrhea (13%)

Dyspepsia (13%)

Cough (13%)

Arthralgia, arthritis (13%)

Peripheral edema (13%)

1-10%

Urinary tract infection (8%)

Bacterial infection (8%)

Cyanosis (8%)

Systemic hypertension (8%)

Gastroenteritis (8%)

Abdominal pain (8%)

Fatigue (8%)

Infusion reaction (8%)

Headache (8%)

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Warnings

Contraindications

Hypersensitivity to sutimlimab or inactive ingredients

Cautions

Monitor for infusion-related reactions and interrupt if reaction occurs; discontinue infusion and institute appropriate supportive measures if signs of hypersensitivity reactions (eg, cardiovascular instability, respiratory compromise) occur

May potentially increase the risk of developing autoimmune diseases such as systemic lupus erythematosus; monitor for signs and symptoms and manage medically

Monitor for signs and symptoms of hemolysis such as elevated levels of total bilirubin or lactate dehydrogenase accompanied by decreased hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria; consider restarting infusion if signs and symptoms of hemolysis occur after discontinuing

Serious infections

  • May increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitidis (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae
  • Serious bacterial and viral infections were reported; infections included sepsis and respiratory and skin infections
  • Vaccination reduces but does not eliminate, risk of encapsulated bacterial infections;some infections may become rapidly life-threatening or fatal if not recognized or treated promptly
  • Inform patients of signs and symptoms of infections and steps to be taken to seek immediate care
  • Vaccinate patients for encapsulated bacteria according to the most current ACIP recommendations for patients with persistent complement deficiencies; revaccinate patients in accordance with ACIP recommendations
  • Immunize patients without a history of vaccination against encapsulated bacteria at ≥2 weeks before receiving initial dose
  • If urgent therapy indicated in unvaccinated patient, administer vaccine(s) as soon as possible
  • If administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection
  • Consider treatment interruption in patients undergoing treatment for serious infection
  • Not studied in patients with chronic systemic infections such as hepatitis B, hepatitis C, or HIV
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Pregnancy & Lactation

Pregnancy

No data are available on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier; therefore, sutimlimab-jome may be transmitted from the mother to the developing fetus

Animal data

  • IV administration of sutimlimab to pregnant monkeys during organogenesis at doses 2 to 3 times the maximum recommended human doses did not result in adverse effects on pregnancy or offspring development

Lactation

There are no data on the presence of sutimlimab-jome in human milk, its effects on breastfed children, or its effects on milk production

Maternal IgG is known to be present in human milk

Effects of local gastrointestinal exposure and limited systemic exposure in breastfed children to sutimlimab-jome are unknown

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Immunoglobulin G (IgG), subclass 4 (IgG4) monoclonal antibody (mAb)

Inhibition of the classic complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of RBCs, resulting in inhibition of hemolysis in patients with CAD

Absorption

Steady-state reached at Week 7

Accumulation ratio: <2

Distribution

Vd: 5.8 L

Sutimlimab binds to C1s in serum

Metabolism

Metabolized by degradation into small peptides and individual amino acids

Elimination

Clearance: 0.14 L/day

Half-life: 21 days

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Administration

IV Incompatibilities

Infusion bags

  • Di-(2-ethylhexyl)phthalate plasticized (DEHP) polyvinyl chloride (PVC)
  • Ethyl vinyl acetate
  • Polyolefin

Administration sets

  • DEHP-plasticized PVC
  • DEHP-free polypropylene
  • Polyethylene

Vial adapters

  • Polycarbonate
  • Acrylonitrile-butadiene-styrene

IV Compatibilities

0.9% NaCl

IV Preparation

Each vial is for single dose only

To minimize foaming, do not shake

Visually inspect vials for particulate matter and discoloration before administration, whenever solution and container permit; solution is clear to slightly opalescent and colorless to slightly yellow; discard if discolored or if foreign particulate matter is present

Dilute solution

  • Withdraw calculated volume from appropriate number of vials and dilute with 0.9% NaCl to total volume of 500 mL
  • 39 to <75 kg: 6,500 mg (130 mL) dilute with 0.9% NaCl 370 mL
  • ≥75 kg: 7,500 mg (150 mL) dilute with 0.9% NaCl 350 mL
  • If not used immediately, refrigerate at 2-8ºC (36-46ºF)
  • Once removed from refrigerator, allow diluted solution to adjust to room temperature 20- 25ºC (68-77ºF) and administer within 8 hr

IV Administration

Infuse over 1-2 hr depending on patient weight

Infusion rates

  • 39 to <70 kg: 250 mL/hr
  • ≥70 kg: 500 mL/hr
  • Patients with cardiopulmonary disease: Infuse over 120 min

Infuse only through 0.2-micron in-line filter with polyethersulfone (PES) membrane

Prime infusion tubing with dosing solution immediately before infusion and flush immediately upon completion with ~20 mL of 0.9% NaCl

Infusion-related reactions

  • Slow or stop infusion if infusion reaction occurs
  • Initial infusion: Monitor for ≥2 hr after completing infusion for signs or symptoms of an infusion and/or hypersensitivity reaction
  • Subsequent infusions: Monitor for 1 hr after completing infusion for signs or symptoms of an infusion reaction

Missed dose

  • Missed dose: Administer as soon as possible; thereafter, resume dosing q2Weeks
  • If last dose >17 days, administer dose weekly for 2 weeks, then q2Weeks thereafter

Storage

Unused vials

  • Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
  • Do not freeze
  • Do not shake
  • Discard unused portion

Diluted solution

  • If not used immediately, refrigerate at 2-8ºC (36-46ºF)
  • Once removed from refrigerator, allow diluted solution to adjust to room temperature 20- 25ºC (68-77ºF) and administer within 8 hr
  • Do not exceed 36 hr total from time of preparation, including refrigeration, adjustment to room temperature, and expected infusion time
  • May use in-line infusion warmers, do not exceed temperature of 40ºC (104ºF)
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Images

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.