Sotatercept Dosage

Medically reviewed by Drugs.com. Last updated on May 6, 2024.

Usual Adult Dose for Pulmonary Hypertension

Initial dose: 0.3 mg/kg subcutaneously every 3 weeks
Maintenance (target) dose: 0.7 mg/kg subcutaneously every 3 weeks

Comments:

• Consult the manufacturer product information for dose calculation examples and kit type recommendations.
• Injection volume equals patient body weight (kg) multiplied by dose (mg/kg), then divided by 50 mg/mL; round volume to nearest 0.1 mL.
• Obtain hemoglobin and platelet count prior to the first dose; do not initiate treatment if platelet count is less than 50,000/mm3 (less than 50 x 10[9]/L).
• Increase to target dose only after verifying acceptable hemoglobin and platelet count.

Use: For the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

DOSE MODIFICATIONS BASED ON HEMOGLOBIN AND PLATELET COUNTS:

• Delay treatment for at least 3 weeks if any of the following occur:
• Hemoglobin increases greater than 2 g/dL from the previous dose and is above the upper limit of normal (ULN)
• Hemoglobin increases greater than 4 g/dL from baseline
• Hemoglobin increases greater than 2 g/dL above ULN
• Platelet count decreases to less than 50,000/mm3 (less than 50 x 10[9]/L)
• Recheck hemoglobin and platelet count before reinitiating treatment.
• For treatment delays lasting more than 9 weeks, restart treatment dosing at 0.3 mg/kg; then, escalate dose to 0.7 mg/kg only after verifying acceptable hemoglobin and platelet count.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug is not dialyzable.

Other Comments

Administration advice:

• For subcutaneous use
• Evaluate hemoglobin and platelet count before each dose for the first 5 doses (or longer if values are unstable), then periodically thereafter.
• Administer injection in the abdomen (at least 2 inches away from navel), upper thigh, or upper arm.
• If administered by the patient or caregiver, inject only in the abdomen or upper thigh.
• Select a new site for each injection; ensure the area is not scarred, tender, or bruised.
• If a dose is missed, administer as soon as possible. If the missed dose is not administered within 3 days of the scheduled date, adjust the schedule to maintain a 3-week dosing interval.

Storage requirements:

• Store vials refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light; do not freeze.
• Kit should remain refrigerated until use but may remain at room temperature (up to 25C [77F]) for up to 24 hours.
• For additional information on temperature excursions, call Merck Sharp & Dohme LLC at 1-800-672-6372.

Reconstitution/preparation techniques:

• This product is supplied as a kit based on injection volume.
• Consult the manufacturer product information for instructions on selecting the appropriate product kit, product reconstitution, and syringe preparation.

General:

• This drug is intended for use under the guidance of a health care professional.
• If considered appropriate, patients and/or caregivers may be trained by a health care provider on the preparation and administration of this drug; ensure proper training follow-up, particularly if the dose changes or the patient requires a different kit.

Monitoring:

• Hematologic: Platelet count and hemoglobin (prior to first 5 doses and then periodically during therapy); for erythrocytosis (in the event of overdose)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Understand that this drug may increase hemoglobin, which may increase the risk of thrombotic events; hemoglobin levels will be assessed prior to and during therapy.
• Be aware that this drug may cause a decrease in platelets, which may cause severe bleeding; platelet levels will be assessed prior to and during therapy.
• Notify your health care provider if any signs and symptoms of bleeding occur.
• Females of childbearing potential:
• Understand the potential risk to a fetus.
• Use effective contraception during treatment and for at least 4 months after the last dose.
• Contact your health care provider if you become (or suspect you are) pregnant.
• Breastfeeding is not recommended during treatment and for 4 months after the last dose.
• Contact your health care provider if you take more than or less than the correct dose, or if a missed dose is not taken within 3 days of the scheduled date.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer