Winrevair 60mg Inj Kit (1 Vial)
It is used to treat high blood pressure in the lungs.
Drug Class
Pulmonary Hypertension Agent
Pharmacologic Class
Activin Receptor Type IIA (ActRIIA) Fc-fusion Protein
Pregnancy Category
Not available
FDA Approved
Mar 2024
DEA Schedule
Not Controlled
Overview
What is this medicine?
Winrevair is an injectable medicine used to treat pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs. It works by helping to reverse the damage to the blood vessels in your lungs, making it easier for your heart to pump blood and improving your ability to exercise.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided.
This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the abdominal area. If you will be self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique.
Before use, wash your hands thoroughly. This medication requires mixing prior to administration, and you should follow the specific instructions provided by your doctor. To prepare the medication, allow the vial to reach room temperature by leaving it at room temperature for 15 minutes. Do not apply heat to the vial. When mixing, avoid shaking the vial. Allow the vial to sit for up to 3 minutes to enable any large bubbles to dissipate.
Visually inspect the medication before use. The solution should be clear to slightly pearly in appearance. Do not use the medication if you notice any clumps, powder, particles, or large bubbles. The solution may be colorless to slightly yellow or slightly brown, but do not use it if the color has changed.
Use the mixed medication within 4 hours of preparation. To minimize the risk of skin irritation, rotate the injection site with each administration. Avoid injecting into skin that is tender, damaged, bruised, sore, or exhibits red patches. Additionally, do not administer the injection within 2 inches (5 cm) of the belly button.
Disposal and Storage
Dispose of used needles and syringes in a designated needle/sharp disposal box. Do not reuse needles or other equipment. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Store the medication in a refrigerator to maintain its potency. Do not freeze the medication. To protect it from light, store the medication in its original outer carton.
Missed Dose
If you miss a dose, administer it as soon as you remember and resume your regular schedule. However, if you miss a dose by more than 3 days, consult your doctor for guidance on how to proceed.
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided.
This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the abdominal area. If you will be self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique.
Before use, wash your hands thoroughly. This medication requires mixing prior to administration, and you should follow the specific instructions provided by your doctor. To prepare the medication, allow the vial to reach room temperature by leaving it at room temperature for 15 minutes. Do not apply heat to the vial. When mixing, avoid shaking the vial. Allow the vial to sit for up to 3 minutes to enable any large bubbles to dissipate.
Visually inspect the medication before use. The solution should be clear to slightly pearly in appearance. Do not use the medication if you notice any clumps, powder, particles, or large bubbles. The solution may be colorless to slightly yellow or slightly brown, but do not use it if the color has changed.
Use the mixed medication within 4 hours of preparation. To minimize the risk of skin irritation, rotate the injection site with each administration. Avoid injecting into skin that is tender, damaged, bruised, sore, or exhibits red patches. Additionally, do not administer the injection within 2 inches (5 cm) of the belly button.
Disposal and Storage
Dispose of used needles and syringes in a designated needle/sharp disposal box. Do not reuse needles or other equipment. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Store the medication in a refrigerator to maintain its potency. Do not freeze the medication. To protect it from light, store the medication in its original outer carton.
Missed Dose
If you miss a dose, administer it as soon as you remember and resume your regular schedule. However, if you miss a dose by more than 3 days, consult your doctor for guidance on how to proceed.
Lifestyle & Tips
- Administer exactly as prescribed by your doctor, typically every 3 weeks.
- Do not miss doses. If a dose is missed, contact your healthcare provider for instructions.
- Store the medication properly as directed (refrigerated, protected from light).
- Report any new or worsening symptoms to your doctor immediately.
- Maintain regular follow-up appointments and blood tests as advised by your doctor.
- Females of reproductive potential must use effective contraception during treatment and for at least 3 months after the last dose.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 0.3 mg/kg subcutaneously every 3 weeks. If tolerated, increase to 0.7 mg/kg subcutaneously every 3 weeks. Max dose: 60 mg per dose.
Dose Range:
0.3 - 0.7 mg
Condition-Specific Dosing:
Pulmonary Arterial Hypertension (PAH):
Initial: 0.3 mg/kg SC every 3 weeks. Titrate to 0.7 mg/kg SC every 3 weeks if tolerated. Max 60 mg/dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required.
Dialysis:
No dose adjustment required. Not studied in patients on dialysis.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required.
Pharmacology
Mechanism of Action
Sotatercept is a recombinant fusion protein that acts as a ligand trap for members of the transforming growth factor-beta (TGF-β) superfamily, specifically activins. In pulmonary arterial hypertension (PAH), there is an imbalance in TGF-β signaling, leading to excessive proliferation of pulmonary artery smooth muscle cells and vascular remodeling. Sotatercept binds to activin A, activin B, and GDF-8, preventing them from binding to their receptors and thereby restoring balance in the BMP/TGF-β signaling pathway, which reduces pulmonary vascular remodeling and improves pulmonary hemodynamics.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70% (subcutaneous)
Tmax:
Approximately 7 days (range: 3-14 days)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 5.8 L
ProteinBinding:
Not applicable (biologic)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 27 days
Clearance:
Approximately 0.14 L/day
ExcretionRoute:
Not primarily renal or hepatic excretion of intact drug; degraded peptides are eliminated.
Unchanged:
Not applicable (biologic)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed within weeks, with sustained effects over time.
PeakEffect:
Not precisely defined for clinical endpoints; hemodynamic improvements seen within weeks to months.
DurationOfAction:
Due to long half-life, effects persist for several weeks after a dose.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred vision
High levels of hemoglobin, which may increase the risk of blood clots. Seek medical attention if you experience:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:
Dizziness
Headache
Nosebleed
Spider veins (visible blood vessels on the skin that appear pink or red)
Diarrhea
Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred vision
High levels of hemoglobin, which may increase the risk of blood clots. Seek medical attention if you experience:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:
Dizziness
Headache
Nosebleed
Spider veins (visible blood vessels on the skin that appear pink or red)
Diarrhea
Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of high red blood cell count (erythrocytosis): headache, dizziness, fatigue, blurred vision, redness of skin.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
- Signs of worsening PAH: increased shortness of breath, chest pain, swelling in legs/ankles, fainting spells.
- Injection site reactions: severe pain, redness, swelling, or bruising at the injection site that does not go away.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as bleeding problems or a low platelet count.
If you are breastfeeding. Note that you should not breastfeed while taking this medication or for 4 months after your last dose.
This medication can interact with various substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as bleeding problems or a low platelet count.
If you are breastfeeding. Note that you should not breastfeed while taking this medication or for 4 months after your last dose.
This medication can interact with various substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.
As this medication may increase your risk of bleeding, it is vital to take precautions to avoid injury. To minimize this risk, use a soft-bristled toothbrush and an electric razor for shaving. Be cautious and gentle to prevent cuts and bruises.
If you experience any changes in weight, consult your doctor, as your dosage may need to be adjusted. Elderly patients, 65 years or older, should exercise extra caution when taking this medication, as the risk of bleeding may be higher in this age group.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss this with your doctor before initiating treatment. Additionally, this medication may harm an unborn baby. To confirm you are not pregnant, a pregnancy test may be required before starting the medication.
If you are of childbearing potential, it is crucial to use effective birth control methods while taking this medication and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control. In the event of pregnancy, notify your doctor immediately.
As this medication may increase your risk of bleeding, it is vital to take precautions to avoid injury. To minimize this risk, use a soft-bristled toothbrush and an electric razor for shaving. Be cautious and gentle to prevent cuts and bruises.
If you experience any changes in weight, consult your doctor, as your dosage may need to be adjusted. Elderly patients, 65 years or older, should exercise extra caution when taking this medication, as the risk of bleeding may be higher in this age group.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss this with your doctor before initiating treatment. Additionally, this medication may harm an unborn baby. To confirm you are not pregnant, a pregnancy test may be required before starting the medication.
If you are of childbearing potential, it is crucial to use effective birth control methods while taking this medication and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control. In the event of pregnancy, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established. Higher doses may increase risk of adverse effects, particularly erythrocytosis.
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Management should be supportive and directed at treating symptoms.
Drug Interactions
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function and monitor for potential hepatotoxicity.
Timing: Prior to initiation
Hemoglobin and Hematocrit
Rationale: To assess baseline red blood cell count, as erythrocytosis is a potential adverse effect.
Timing: Prior to initiation
Pregnancy test
Rationale: To rule out pregnancy in females of reproductive potential due to potential fetal harm.
Timing: Prior to initiation
Functional Class (WHO/NYHA)
Rationale: To establish baseline disease severity.
Timing: Prior to initiation
6-Minute Walk Distance (6MWD)
Rationale: To establish baseline exercise capacity.
Timing: Prior to initiation
Routine Monitoring
Hemoglobin and Hematocrit
Frequency: Prior to each dose for the first 5 doses, then periodically as clinically indicated.
Target: Within normal limits; monitor for erythrocytosis.
Action Threshold: If hemoglobin > 16 g/dL (females) or > 17 g/dL (males), consider dose interruption or phlebotomy.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically as clinically indicated.
Target: Within normal limits.
Action Threshold: Elevations may warrant dose interruption or discontinuation.
Functional Class (WHO/NYHA)
Frequency: Periodically (e.g., every 3-6 months).
Target: Improvement or stabilization.
Action Threshold: Worsening may indicate need for re-evaluation of treatment strategy.
6-Minute Walk Distance (6MWD)
Frequency: Periodically (e.g., every 3-6 months).
Target: Improvement or stabilization.
Action Threshold: Worsening may indicate need for re-evaluation of treatment strategy.
Pregnancy test
Frequency: Monthly for females of reproductive potential.
Target: Negative.
Action Threshold: Positive test requires immediate discontinuation and counseling.
Symptom Monitoring
- Signs of erythrocytosis (e.g., headache, dizziness, fatigue, blurred vision)
- Signs of liver injury (e.g., unexplained nausea, vomiting, abdominal pain, dark urine, jaundice)
- Signs of worsening PAH (e.g., increased dyspnea, fatigue, edema, syncope)
- Injection site reactions (e.g., pain, redness, swelling, bruising)
Special Patient Groups
Pregnancy
Winrevair may cause fetal harm when administered to a pregnant woman. Based on findings from animal reproduction studies, it is contraindicated in pregnancy. Females of reproductive potential must have a negative pregnancy test prior to initiation and use effective contraception during treatment and for at least 3 months after the last dose.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data.
Second Trimester:
Potential for fetal harm based on animal data.
Third Trimester:
Potential for fetal harm based on animal data.
Lactation
It is unknown if sotatercept is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment and for 3 months after the last dose.
Infant Risk:
Unknown; potential for serious adverse reactions.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not indicated for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (âĨ65 years) and younger patients. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Winrevair is the first-in-class activin signaling inhibitor approved for PAH, representing a novel therapeutic approach beyond traditional vasodilators.
- It is intended to be added to existing PAH background therapy.
- Patients should be monitored for erythrocytosis, and phlebotomy may be considered if hemoglobin levels become too high.
- Due to its long half-life, the every 3-week dosing schedule can improve adherence.
- Requires careful patient selection and monitoring due to its mechanism of action and potential for specific adverse effects.
Alternative Therapies
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil)
- Endothelin Receptor Antagonists (ERAs) (e.g., ambrisentan, bosentan, macitentan)
- Prostacyclin pathway agents (e.g., epoprostenol, treprostinil, iloprost, selexipag)
- Soluble Guanylate Cyclase (sGC) stimulators (e.g., riociguat)
Cost & Coverage
Average Cost:
Very high (e.g., $14,000 - $28,000+) per vial (60mg)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.