Sotatercept

Sotatercept is a prescription medication indicated for pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

• Sotatercept is available under the following different brand names: Winrevair, sotatercept-csrk.

Common side effects of Sotatercept include:

• headache
• nose bleeds
• rash
• tiny blood vessels that look like pink or red lines on the skin (spider veins)
• diarrhea
• dizziness
• redness

Serious side effects of Sotatercept include:

• high level of hemoglobin in the blood
• severely low platelet levels in the blood
• serious bleeding symptoms include vomiting blood or vomit that looks like coffee grounds, nausea, dizziness or feeling weak, pink, or brown urine, persistent abdominal cramps, red or black stools that look like tar, severe back pain, coughing up blood or blood clots, abnormally heavy menstrual bleeding, persistent headaches
• decreased fertility

Rare side effects of Sotatercept include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Pulmonary arterial hypertension

• Starting dose
  • Obtain hemoglobin (Hgb) and platelet count before the first dose; do not initiate treatment if the platelet count is less than 50,000/mm3 (below 50 x 109/L)
  • 0.3 mg/kg SC every 3 weeks
  • 0.3 mg/kg dose calculation of injection volume
  • Injection volume (mL) = (Weight [kg] x 0.3 mg/kg) ÷ 50 mg/kg
  • Round to the nearest 0.1 mL
  • Example: (70 kg x 0.3 mg/kg) ÷ 50 mg/mL = 0.42 mL, rounds to 0.4 mL
• Target dose
  • After verifying acceptable Hgb and platelet count, increase to target dose
  • 0.7 mg/kg SC every 3 weeks; continue unless dosage adjustment required
  • 0.7 mg/kg dose calculation of injection volume
  • Injection volume (mL) = (Weight [kg] x 0.7 mg/kg) ÷ 50 mg/kg
  • Round to the nearest 0.1 mL
  • Example: (70 kg x 0.7 mg/kg) ÷ 50 mg/mL = 0.98 mL, rounds to 1 mL

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sotatercept has no noted severe interactions with any other drugs
• Sotatercept has no noted serious interactions with any other drugs
• Sotatercept has no noted moderate interactions with any other drugs
• Sotatercept has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

• Contraindications
• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sotatercept?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sotatercept?”

Cautions

• Erythrocytosis
  • May increase hemoglobin
  • Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome
  • Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required
• Severe thrombocytopenia
  • May decrease platelet count
  • Severe thrombocytopenia may increase the risk of bleeding
  • Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion
  • Do not initiate treatment if the platelet count is less than 50,000/mm3
  • Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required
• Serious bleeding
  • Serious bleeding (eg, gastrointestinal, intracranial hemorrhage) reported
  • Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts
  • Advise patients about the signs and symptoms of blood loss
  • Evaluate and treat bleeding accordingly
  • Do not administer if the patient is experiencing serious bleeding
• Embryo-fetal toxicity
  • Based on findings in animal reproduction studies, may cause fetal harm when administered to pregnant women
  • Advise pregnant women of potential fetal risk
  • Advise women of reproductive potential to use an effective method of contraception during treatment and for at least 4 months after the final dose
• Impaired fertility
  • Based on findings in animals, it may impair women's and men's fertility
  • Advise patients on potential effects on fertility

Pregnancy and Lactation

• Based on findings in animal reproduction studies, can cause fetal harm when administered to a pregnant women
• Pregnancy testing is recommended for women of reproductive potential before starting treatment
• Clinical considerations
  • In patients with PAH, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction, and premature labor
• Contraception
  • Advise women patients of reproductive potential to use effective contraception during treatment and for at least 4 months after the final dose if treatment is discontinued
• Infertility
  • Based on findings in animals, Sotatercept may impair women's and men's fertility
• Lactation
  • Data are not available regarding the presence of Sotatercept in human milk, its effects on breastfed infants, or its effects on milk production
  • Because of the potential for serious adverse reactions in breastfed children, advise patients that breastfeeding is not recommended during treatment and for 4 months after the final dose