Skytrofa 6.3mg Inj Cartridge
It is used to help with growth and to treat growth hormone deficiency.
Drug Class
Growth Hormone
Pharmacologic Class
Recombinant Human Growth Hormone (rhGH) Analog; Somatropin Prodrug
Pregnancy Category
Not available
FDA Approved
Aug 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Skytrofa is a medicine used to help children grow taller when their bodies don't make enough natural growth hormone. It's given as a shot under the skin once a week. It works by slowly releasing the growth hormone your child needs to grow.
How to Use This Medicine
Proper Administration of This Medication
To ensure your child receives this medication safely and effectively, follow the instructions provided by their doctor. Carefully read all accompanying information and adhere to the guidelines outlined below.
This medication is administered via injection into the fatty tissue of the skin, typically on the right or left side of the stomach, thigh, or buttocks. If you will be giving your child the injection, their doctor or nurse will provide personalized instruction on the proper technique.
Before administering the medication, make sure you understand the instructions for use. If you have any questions or concerns, consult with the doctor or pharmacist. If the medication has been stored in the refrigerator, allow it to reach room temperature for 15 minutes before use. Do not heat the medication.
Preparation and Administration
This medication requires mixing before use. Follow the mixing instructions provided by the doctor. Rotate the injection site with each administration to minimize the risk of irritation or other complications. Avoid injecting through clothing, and do not administer the medication into skin that is irritated, bruised, red, infected, hard, or scarred.
Wash your hands thoroughly before and after handling the medication. Inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the medication if it has changed color or exhibits any of these characteristics. After mixing, do not refrigerate the medication. Use the medication within 4 hours of preparation and discard any unused portion.
Disposal and Storage
Dispose of used needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with the doctor or pharmacist.
Store the medication in the refrigerator, avoiding freezing temperatures. Keep the medication in its original carton to protect it from light. If necessary, you may store the medication at room temperature for up to 6 months. Record the date you remove the medication from the refrigerator and return it to the refrigerator within the 6-month period. Discard the medication if it is not used within 6 months of removal from the refrigerator.
Missed Dose Instructions
If a dose is missed, administer it as soon as possible. However, if your child misses a dose by more than 2 days, skip the missed dose and resume the regular schedule. Do not administer two doses within a 5-day period.
To ensure your child receives this medication safely and effectively, follow the instructions provided by their doctor. Carefully read all accompanying information and adhere to the guidelines outlined below.
This medication is administered via injection into the fatty tissue of the skin, typically on the right or left side of the stomach, thigh, or buttocks. If you will be giving your child the injection, their doctor or nurse will provide personalized instruction on the proper technique.
Before administering the medication, make sure you understand the instructions for use. If you have any questions or concerns, consult with the doctor or pharmacist. If the medication has been stored in the refrigerator, allow it to reach room temperature for 15 minutes before use. Do not heat the medication.
Preparation and Administration
This medication requires mixing before use. Follow the mixing instructions provided by the doctor. Rotate the injection site with each administration to minimize the risk of irritation or other complications. Avoid injecting through clothing, and do not administer the medication into skin that is irritated, bruised, red, infected, hard, or scarred.
Wash your hands thoroughly before and after handling the medication. Inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the medication if it has changed color or exhibits any of these characteristics. After mixing, do not refrigerate the medication. Use the medication within 4 hours of preparation and discard any unused portion.
Disposal and Storage
Dispose of used needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with the doctor or pharmacist.
Store the medication in the refrigerator, avoiding freezing temperatures. Keep the medication in its original carton to protect it from light. If necessary, you may store the medication at room temperature for up to 6 months. Record the date you remove the medication from the refrigerator and return it to the refrigerator within the 6-month period. Discard the medication if it is not used within 6 months of removal from the refrigerator.
Missed Dose Instructions
If a dose is missed, administer it as soon as possible. However, if your child misses a dose by more than 2 days, skip the missed dose and resume the regular schedule. Do not administer two doses within a 5-day period.
Lifestyle & Tips
- Store Skytrofa in the refrigerator (36°F to 46°F / 2°C to 8°C). Do not freeze.
- Protect from light. Keep the cartridge in its original carton.
- After first use, the cartridge can be stored at room temperature (up to 77°F / 25°C) for up to 7 days, or in the refrigerator for up to 28 days. Discard after these periods.
- Always use a new needle for each injection.
- Rotate injection sites (thighs, buttocks, abdomen, upper arms) to prevent skin problems.
- Follow the instructions for use provided with the Skytrofa Auto-Injector carefully.
- Keep all appointments for blood tests and doctor visits to monitor treatment effectiveness and safety.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult growth hormone deficiency.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial dose 0.24 mg/kg body weight administered once weekly by subcutaneous injection. Dose should be individualized based on growth response and IGF-1 levels. Adjust dose in increments of 0.04 mg/kg/week.
Adolescent:
Initial dose 0.24 mg/kg body weight administered once weekly by subcutaneous injection. Dose should be individualized based on growth response and IGF-1 levels. Adjust dose in increments of 0.04 mg/kg/week.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely.
Moderate:
No specific dose adjustment recommended, but monitor closely.
Severe:
No specific dose adjustment recommended, but monitor closely. Use with caution.
Dialysis:
Not available. Use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely.
Moderate:
No specific dose adjustment recommended, but monitor closely.
Severe:
No specific dose adjustment recommended, but monitor closely. Use with caution.
Confidence:
Medium
Pharmacology
Mechanism of Action
Lonapegsomatropin is a prodrug of somatropin. It is a long-acting C-terminally pegylated somatropin that undergoes proteolytic cleavage in vivo to slowly release unconjugated somatropin. Somatropin binds to growth hormone (GH) receptors on target cells, stimulating linear growth, and increasing protein, carbohydrate, and lipid metabolism. It mediates its effects by stimulating the production of insulin-like growth factor-1 (IGF-1) and IGF-binding protein-3 (IGFBP-3).
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for lonapegsomatropin, but somatropin is released systemically.
Tmax:
Median Tmax for released somatropin is approximately 108 hours (4.5 days) after subcutaneous administration of lonapegsomatropin.
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
Not explicitly reported for lonapegsomatropin; for released somatropin, Vd is approximately 0.49 L/kg.
ProteinBinding:
Not explicitly reported for lonapegsomatropin; for somatropin, it binds to growth hormone binding protein (GHBP).
CnssPenetration:
Limited
Elimination:
HalfLife:
Effective half-life of released somatropin is approximately 25-30 hours, allowing for once-weekly dosing.
Clearance:
Not explicitly reported for lonapegsomatropin; for somatropin, clearance is approximately 0.14 L/hr/kg.
ExcretionRoute:
Renal (somatropin and its metabolites).
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Not acutely measurable for growth, but IGF-1 levels begin to rise within days.
PeakEffect:
Peak IGF-1 levels are typically observed within 1-2 weeks after initiation of therapy and after dose adjustments.
DurationOfAction:
Sustained release of somatropin over 7 days, supporting once-weekly dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If your child exhibits any of the following symptoms, contact their doctor or seek medical attention immediately:
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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of low thyroid levels, such as:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations that are not normal
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
A skin lump or growth
Changes in the color or size of a mole
Skin breakdown at the site of application
Unexplained bruising or bleeding
Muscle or joint pain
Burning, numbness, pain, or tingling in the hands, arms, wrists, legs, or feet
Children who use this medication can rarely experience a bone problem in the hip (slipped growth plate); seek medical attention if your child has hip or knee pain or a limp
Severe bone problems have been reported; contact the doctor if your child experiences new or worsening bone pain
Raised pressure in the head has rarely occurred, particularly in patients with Turner syndrome or Prader-Willi syndrome; seek medical help if your child experiences:
+ Changes in vision
+ Severe headache
+ Upset stomach
+ Vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If your child experiences any of the following side effects or any other symptoms that bother them or do not go away, contact their doctor:
Upset stomach or vomiting
* Stomach pain or diarrhea
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your child's doctor. For medical advice about side effects, contact your child's doctor.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If your child exhibits any of the following symptoms, contact their doctor or seek medical attention immediately:
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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of low thyroid levels, such as:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations that are not normal
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
A skin lump or growth
Changes in the color or size of a mole
Skin breakdown at the site of application
Unexplained bruising or bleeding
Muscle or joint pain
Burning, numbness, pain, or tingling in the hands, arms, wrists, legs, or feet
Children who use this medication can rarely experience a bone problem in the hip (slipped growth plate); seek medical attention if your child has hip or knee pain or a limp
Severe bone problems have been reported; contact the doctor if your child experiences new or worsening bone pain
Raised pressure in the head has rarely occurred, particularly in patients with Turner syndrome or Prader-Willi syndrome; seek medical help if your child experiences:
+ Changes in vision
+ Severe headache
+ Upset stomach
+ Vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If your child experiences any of the following side effects or any other symptoms that bother them or do not go away, contact their doctor:
Upset stomach or vomiting
* Stomach pain or diarrhea
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your child's doctor. For medical advice about side effects, contact your child's doctor.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache, especially with nausea, vomiting, or vision changes (could be signs of increased pressure in the brain)
- Limping or new hip/knee pain (could be slipped capital femoral epiphysis)
- Changes in skin moles or new skin lesions (rare risk of malignancy)
- Increased thirst, increased urination, or unexplained weight loss (signs of high blood sugar)
- Unusual tiredness, weight gain, constipation, or feeling cold (signs of low thyroid function)
- Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue, difficulty breathing or swallowing
- Pain, redness, or swelling at the injection site that doesn't go away
Before Using This Medicine
Before Your Child Takes This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please describe the allergic reaction and its symptoms.
If your child has a history of certain health conditions, such as:
+ Breathing problems, including sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
If your child has Prader-Willi syndrome and is severely overweight, experiences breathing difficulties, or has sleep apnea
If your child's bones have stopped growing (closed epiphyses)
This list is not exhaustive, and it is crucial to discuss all your child's medications (prescription, over-the-counter, natural products, and vitamins) and health problems with the doctor and pharmacist. To ensure safe treatment, verify that it is safe to administer this medication with all your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please describe the allergic reaction and its symptoms.
If your child has a history of certain health conditions, such as:
+ Breathing problems, including sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
If your child has Prader-Willi syndrome and is severely overweight, experiences breathing difficulties, or has sleep apnea
If your child's bones have stopped growing (closed epiphyses)
This list is not exhaustive, and it is crucial to discuss all your child's medications (prescription, over-the-counter, natural products, and vitamins) and health problems with the doctor and pharmacist. To ensure safe treatment, verify that it is safe to administer this medication with all your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.
Your child may be at risk for high blood sugar, including the development of new or worsening diabetes. To monitor this, follow the doctor's instructions for checking your child's blood sugar levels. Additionally, adhere to the recommended schedule for your child's blood work and eye exams as advised by their doctor.
This medication may interfere with certain laboratory tests. Be sure to notify all of your child's healthcare providers and laboratory personnel that your child is taking this drug.
If your child experiences any changes in weight, consult with their doctor, as this may necessitate an adjustment in the dosage of this medication.
Do not share this product, including needles or syringes, with anyone else, even if the needle has been changed. Sharing can lead to the transmission of infections, including those that may not be immediately apparent.
One of the potential side effects of this medication is an excessive accumulation of fluid in the body, which can, in some cases, lead to heart failure. If your child exhibits symptoms such as shortness of breath, significant weight gain, or swelling in the arms or legs, contact their doctor immediately.
If your child has scoliosis, an abnormal curvature of the spine, discuss this with their doctor, as this medication may exacerbate the condition in children who are still growing.
In children with a history of cancer or tumors, the use of this medication may increase the risk of cancer or tumor growth. Furthermore, the development of new tumors may also be a concern for some patients. Consult with your child's doctor to discuss these potential risks.
Children with Prader-Willi syndrome are at a higher risk for severe and potentially life-threatening respiratory problems. This risk may be increased in children who have sleep apnea, lung or airway infections, airway obstruction, or are severely overweight. If your child has a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worsening snoring, or abnormal breathing during sleep, contact their doctor immediately.
If your child is pregnant or breastfeeding, it is crucial to discuss the benefits and risks of this medication with their doctor, as it may affect both your child and the baby.
Your child may be at risk for high blood sugar, including the development of new or worsening diabetes. To monitor this, follow the doctor's instructions for checking your child's blood sugar levels. Additionally, adhere to the recommended schedule for your child's blood work and eye exams as advised by their doctor.
This medication may interfere with certain laboratory tests. Be sure to notify all of your child's healthcare providers and laboratory personnel that your child is taking this drug.
If your child experiences any changes in weight, consult with their doctor, as this may necessitate an adjustment in the dosage of this medication.
Do not share this product, including needles or syringes, with anyone else, even if the needle has been changed. Sharing can lead to the transmission of infections, including those that may not be immediately apparent.
One of the potential side effects of this medication is an excessive accumulation of fluid in the body, which can, in some cases, lead to heart failure. If your child exhibits symptoms such as shortness of breath, significant weight gain, or swelling in the arms or legs, contact their doctor immediately.
If your child has scoliosis, an abnormal curvature of the spine, discuss this with their doctor, as this medication may exacerbate the condition in children who are still growing.
In children with a history of cancer or tumors, the use of this medication may increase the risk of cancer or tumor growth. Furthermore, the development of new tumors may also be a concern for some patients. Consult with your child's doctor to discuss these potential risks.
Children with Prader-Willi syndrome are at a higher risk for severe and potentially life-threatening respiratory problems. This risk may be increased in children who have sleep apnea, lung or airway infections, airway obstruction, or are severely overweight. If your child has a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worsening snoring, or abnormal breathing during sleep, contact their doctor immediately.
If your child is pregnant or breastfeeding, it is crucial to discuss the benefits and risks of this medication with their doctor, as it may affect both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute overdose: Hypoglycemia (low blood sugar) initially, followed by hyperglycemia (high blood sugar).
- Chronic overdose: Signs and symptoms of gigantism (in children) or acromegaly (in adults), including excessive growth, enlarged hands/feet, joint pain, and other metabolic disturbances.
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222. Management involves supportive care, monitoring blood glucose levels, and discontinuing the medication. Long-term management of chronic overdose involves discontinuing the drug and addressing any resulting complications.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of lonapegsomatropin; avoid concomitant use or adjust glucocorticoid dose)
- Insulin and/or other antidiabetic agents (may require dose adjustment due to potential for hyperglycemia)
Moderate Interactions
- Thyroid hormone (may need dose adjustment of thyroid hormone as growth hormone can accelerate T4 to T3 conversion)
- Oral estrogen (may decrease IGF-1 response to growth hormone; higher doses of lonapegsomatropin may be required)
Minor Interactions
- CYP450 metabolized drugs (growth hormone may induce CYP3A4, potentially altering metabolism of drugs cleared by this pathway, e.g., corticosteroids, sex steroids, cyclosporine)
Monitoring
Baseline Monitoring
Height and Weight
Rationale: To establish baseline growth velocity and calculate initial dose.
Timing: Prior to initiation of therapy
IGF-1 and IGFBP-3 levels
Rationale: To assess baseline growth hormone status and guide initial dosing.
Timing: Prior to initiation of therapy
Thyroid Function Tests (TSH, free T4)
Rationale: To rule out hypothyroidism, which can mimic GHD and affect growth response.
Timing: Prior to initiation of therapy
Fasting Glucose and HbA1c
Rationale: To assess baseline glucose metabolism due to potential for hyperglycemia.
Timing: Prior to initiation of therapy
Bone Age
Rationale: To assess skeletal maturity and predict adult height potential.
Timing: Prior to initiation of therapy
Fundoscopic Examination
Rationale: To rule out papilledema, especially in patients with pre-existing intracranial lesions or risk factors for pseudotumor cerebri.
Timing: Prior to initiation of therapy
Routine Monitoring
Height and Weight
Frequency: Every 3-6 months
Target: Improved growth velocity, appropriate weight gain
Action Threshold: Lack of adequate growth response or excessive weight gain may indicate need for dose adjustment or re-evaluation.
IGF-1 levels
Frequency: Every 3-6 months, or 4-6 weeks after dose adjustment
Target: Within age- and sex-appropriate normal range (0 to +2 SDS)
Action Threshold: Levels consistently above +2 SDS may indicate overdose and require dose reduction; levels consistently below -2 SDS may indicate underdosing and require dose increase.
Thyroid Function Tests (TSH, free T4)
Frequency: Every 6-12 months, or if clinical signs of hypothyroidism develop
Target: Within normal limits
Action Threshold: Abnormal levels require evaluation and potential thyroid hormone replacement.
Fasting Glucose and HbA1c
Frequency: Annually, or if clinical signs of glucose intolerance develop
Target: Within normal limits
Action Threshold: Elevated levels require further investigation and potential management of glucose intolerance.
Fundoscopic Examination
Frequency: Annually, or if symptoms of pseudotumor cerebri (e.g., severe headache, visual changes) develop
Target: No papilledema
Action Threshold: Presence of papilledema requires immediate discontinuation of therapy and neuro-ophthalmologic evaluation.
Scoliosis screening
Frequency: Annually during periods of rapid growth
Target: No progression of scoliosis
Action Threshold: Progression of pre-existing scoliosis or new onset requires orthopedic evaluation.
Symptom Monitoring
- Severe or recurrent headache
- Visual changes (e.g., blurred vision, double vision)
- Nausea or vomiting
- Limping or hip/knee pain (slipped capital femoral epiphysis)
- New or worsening skin lesions (for malignancy risk)
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
- Signs of hyperglycemia (increased thirst, urination, fatigue)
- Signs of hypothyroidism (fatigue, weight gain, constipation, cold intolerance)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of lonapegsomatropin in pregnant women. Animal reproduction studies have not been conducted with lonapegsomatropin. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Not specifically studied. Growth hormone is a protein and generally not expected to cross the placenta significantly.
Second Trimester:
Not specifically studied. Potential for effects on maternal glucose metabolism.
Third Trimester:
Not specifically studied. Potential for effects on maternal glucose metabolism.
Lactation
It is not known whether lonapegsomatropin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from lonapegsomatropin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Unknown. As a large protein, it is unlikely to be absorbed intact by the infant if present in milk, but potential for adverse effects cannot be excluded.
Pediatric Use
Skytrofa is indicated for the treatment of pediatric patients 1 year and older with growth hormone deficiency (GHD). Dosing is weight-based and adjusted according to IGF-1 levels and growth response. Safety and effectiveness in infants younger than 1 year have not been established.
Geriatric Use
The safety and effectiveness of Skytrofa in geriatric patients have not been established. Skytrofa is not indicated for adult GHD. Elderly patients may be more sensitive to the actions of somatropin and may be at increased risk for adverse reactions.
Clinical Information
Clinical Pearls
- Skytrofa is the first once-weekly growth hormone treatment approved for pediatric GHD, offering a significant convenience advantage over daily injections.
- It is a prodrug that slowly releases somatropin, providing sustained therapeutic levels.
- Dosing is individualized based on IGF-1 levels and growth response, requiring careful monitoring.
- Patients and caregivers must be thoroughly trained on proper subcutaneous injection technique and auto-injector use.
- Regular monitoring of IGF-1, thyroid function, and glucose metabolism is crucial to optimize therapy and manage potential side effects.
- Patients should be monitored for signs of pseudotumor cerebri, slipped capital femoral epiphysis, and progression of scoliosis.
Alternative Therapies
- Daily recombinant human growth hormone (rhGH) products (e.g., Norditropin, Genotropin, Humatrope, Saizen, Omnitrope, Zomacton)
- Other long-acting growth hormone products (e.g., Somatrogon-ghla (Ngenla), which is also weekly)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per cartridge
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. Some medications may come with an additional patient information leaflet; if you have any questions or concerns about this medication, consult with your child's doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.