Version October 2024
Dosage guidance:
Safety: Assess Hb and platelet count prior to each dose for the first 5 doses (or longer if values are unstable); do not initiate therapy if platelet count is <50,000/mm3.
Pulmonary arterial hypertension: SUBQ: Initial: 0.3 mg/kg once every 3 weeks; increase to target dose 0.7 mg/kg once every 3 weeks once Hb and platelet counts are verified to be within an acceptable range.
Missed dose: Administer a missed dose as soon as possible; if the missed dose is not administered within 3 days of the originally scheduled date, adjust the schedule to maintain a 3-week dosing interval.
There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant pharmacokinetic differences were observed in patients with kidney impairment.
Dialysis: Not dialyzable.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Bleeding, severe: Hold sotatercept therapy and institute proper treatment.
Hemoglobin (increases >2 g/dL from the previous dose and is above ULN, increases >4 g/dL from baseline, or increases >2 g/dL above ULN): Hold sotatercept therapy for at least 3 weeks and recheck Hb before reinitiating therapy. Note: For treatment delays >9 weeks, restart sotatercept therapy at 0.3 mg/kg and increase to 0.7 mg/kg once Hb is at an acceptable level.
Platelets (decreases to <50,0000/mm3): Hold sotatercept therapy for at least 3 weeks and recheck platelets before reinitiating therapy. Note: For treatment delays >9 weeks, restart sotatercept therapy at 0.3 mg/kg and increase to 0.7 mg/kg once platelets are at an acceptable level.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Dermatologic: Erythema of skin (14%), skin rash (20%), telangiectasia (17%)
Gastrointestinal: Diarrhea (15%)
Hematologic & oncologic: Decreased platelet count (25%; severe: 3%), increased hemoglobin (53%)
Immunologic: Antibody development (27%; neutralizing: 7%)
Nervous system: Dizziness (15%), headache (25%)
Respiratory: Epistaxis (22%)
1% to 10%: Hematologic & oncologic: Hemorrhage (4%; including gastrointestinal hemorrhage, intracranial hemorrhage)
Frequency not defined: Cardiovascular: Increased blood pressure
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Erythrocytosis: Increases in Hb may occur, which may increase the risk of thromboembolic events or hyperviscosity syndrome; dosage adjustments may be needed.
• Thrombocytopenia/bleeding: Severe thrombocytopenia leading to an increased risk of bleeding may occur; reported more frequently in patients also receiving prostacyclin infusions. Severe bleeding (eg, GI and intracranial hemorrhage) was reported.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Subcutaneous:
Winrevair: Sotatercept-csrk 60 mg, Sotatercept-csrk 2 x 60 mg [contains polysorbate 80]
Kit, Subcutaneous [preservative free]:
Winrevair: Sotatercept-csrk 45 mg, Sotatercept-csrk 2 x 45 mg [contains polysorbate 80]
No
Kit (Winrevair Subcutaneous)
2 x 45 mg (per each): $33,600.00
2 x 60 mg (per each): $33,600.00
45 mg (per each): $16,800.00
60 mg (per each): $16,800.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SUBQ: For SUBQ administration only; may be administered by patient or caregiver after proper training. Product is available as a 1-vial kit or a 2-vial kit; if a patient’s body weight requires a 2-vial kit (use of two 45 mg vials or two 60 mg vials), use the 2-vial kit rather than two individual 1-vial kits; this will aid in proper measuring of the dose and avoid the need for multiple injections. Administer into the abdomen (≥2 inches from the navel), upper arm (if administered by health care provider), or upper thigh; rotate sites with each injection. Do not administer into bruised, scarred, or tender skin.
Pulmonary arterial hypertension: Treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults.
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to use; pregnancy testing is recommended prior to use in patients who may become pregnant.
Patients who may become pregnant should use effective contraception during therapy and for at least 4 months after the last dose of sotatercept.
Based on data from animal reproduction studies, in utero exposure to sotatercept may cause fetal harm. Adverse events were observed following SUBQ administration of sotatercept to pregnant rats at 4 times and pregnant rabbits at 0.6 times the maximum recommended human dose (based on AUC).
It is not known if sotatercept is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 4 months after the last dose of sotatercept.
Obtain Hb and platelet count prior to each dose for the first 5 doses (longer if values are unstable) then monitor periodically; evaluate pregnancy status prior to initiation (in patients who could become pregnant); signs and symptoms of bleeding.
Sotatercept is a homodimeric recombinant fusion protein that contains a modified form of the extracellular domain of human activin receptor type IIa and links to the human IgG1 Fc domain. It binds several endogenous transforming growth factor-beta (TGF-β) superfamily ligands, which results in a balance between pro-proliferative ActRIIA/Smad2/3 and anti-proliferative BMPRII/Smad 1/5/8 signaling to modulate vascular proliferation.
Distribution: Vdss: ~5.3 L.
Metabolism: Into small peptides by catabolic pathways.
Bioavailability: ~66%.
Half-life elimination: ~24 days.
Time to peak: ~7 days (range: 2 to 8 days).
Excretion: Clearance: ~0.18 L/day.
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