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Increlex (mecasermin) is used to treat children who are very short for their age because their bodies do not make enough insulin-like growth factor-1 (IGF-1). This condition is called Severe Primary IGF-1 Deficiency or SPIGFD. Increlex should not be used instead of growth hormone and has not been studied for use in children under 2 years of age.
Increlex (mecasermin) is a prescription medication that contains recombinant human insulin-like growth factor-1 (IGF-1). It is used for the treatment of a rare medical condition known as growth hormone insensitivity syndrome (GHIS), also referred to as insulin-like growth factor-1 deficiency (IGFD).
If your child is not growing at a rate that they should be and their growth hormone levels are normal, very low levels of IGF-1 may be the cause. Talk to your doctor about having your child screened for Severe Primary IGF-1 Deficiency. Ask your doctor for more information to find out if Increlex is an appropriate treatment option for your child.
What is Increlex?
- Active Ingredient: Mecasermin, a man-made version of human IGF-1.
- Function: Replaces missing IGF-1 to help bones and muscles grow.
- Limits: It is not a growth hormone and does not treat short stature caused by growth hormone deficiency, poor nutrition, low thyroid levels, or steroid use.
How It Is Used
- Administration: Given as a shot under the skin (subcutaneously).
- Timing: Inject shortly (about 20 minutes) before or after a meal or snack. Skip the dose if a meal is missed.
- Site Rotation: Change the injection site (stomach, thigh, upper arm, or buttocks) with each dose. Never inject into a vein.
- Dosage: Set by a doctor based on body weight
Generic Name: Mecasermin
Brand name: Increlex
GHIS is a genetic disorder characterized by a lack of response to growth hormone (GH), which leads to short stature and poor growth in affected individuals. Normally, GH is produced by the pituitary gland and stimulates the production of IGF-1 in the liver. IGF-1 plays a crucial role in promoting the growth and development of bones, muscles, and other tissues.
However, individuals with GHIS have a defect in the GH receptor or related signaling pathways, which results in reduced production of IGF-1 and impaired growth. Increlex, being a form of recombinant IGF-1, can help address this deficiency and promote linear growth in children with GHIS.
Key points about Increlex:
Indication: Increlex is indicated for the long-term treatment of children with growth failure due to severe primary IGF-1 deficiency (GHIS/IGFD) or with GH gene deletion who have developed neutralizing antibodies to GH.
Administration: Increlex is administered by subcutaneous (under the skin) injection. It is usually given once or twice daily, depending on the specific treatment plan recommended by the healthcare provider.
Monitoring: Regular monitoring of growth and IGF-1 levels is essential to adjust the dose and ensure optimal treatment outcomes.
Adverse Effects: Like any medication, Increlex can have side effects. Common side effects may include injection site reactions, headaches, and low blood sugar (hypoglycemia). Your doctor will monitor for these and other potential side effects.
Contraindications: Increlex should not be used in individuals with a known hypersensitivity to mecasermin or any of its components.
Usage in Athletes: It’s important to note that IGF-1, including Increlex, has been abused by some athletes and bodybuilders for its potential to enhance muscle growth and performance. However, such use is not approved and can lead to serious health risks.
Important Safety Information
- When to Avoid: Do not use if the child has closed bone growth plates, an allergy to IGF-1, or active/history of cancer.
- Low Blood Sugar (Hypoglycemia): Increlex can lower blood sugar levels. Avoid tasks requiring alertness (like heavy exercise) for 2 to 3 hours after injecting.
- Common Side Effects: Include headache, low blood sugar, vomiting, and lumps at the injection site
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Increlex (mecasermin) is a prescription injection used to treat growth failure in children aged 2 years and older with severe primary insulin-like growth factor-1 (igf-1) deficiency
Increlex For Sale Online Without Prescription
Increlex (mecasermin) is an injection used to treat growth failure in children aged 2 years and older with severe primary insulin-like growth factor-1 (igf-1) deficiency
Who Should Not Receive Increlex ?
Your child should not receive Increlex if your child:
- is allergic to mecasermin or any of the ingredients in Increlex ;
- has finished growing;
- has any cancerous tumors or growths;
- or has a history of cancer.
What Should I Tell My Child’s Doctor Before My Child Starts Increlex ?
What Are Possible Side Effects of Increlex ?
Low blood sugar (hypoglycemia).
Increlex may lower blood sugar levels. It is important to only give your child Increlex 20 minutes before or 20 minutes after a meal or snack to reduce the chances of low blood sugar. Do not give your child Increlex if your child cannot eat. Signs of low blood sugar include: dizziness; tiredness; restlessness; hunger; irritability; trouble concentrating; sweating; nausea; and fast or irregular heartbeat. Severe low blood sugar may cause unconsciousness, seizures, or death. Your child should avoid participating in high risk activities (e.g., driving, exercise, etc.) within 2 to 3 hours after the Increlex injection, especially at the beginning of treatment. Your child should always have a source of sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of low blood sugar happen. For severe low blood sugar, if your child is not responsive and cannot drink sugar-containing fluids, you should get emergency medical help for your child right away.
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Allergic reactions.
are a serious but common side effect of Increlex . Call your child’s doctor right away if your child gets a rash or hives, which generally appear minutes to hours after the injection and may sometimes occur at many places on the skin. Stop taking Increlex and get medical help right away if your child has trouble breathing or goes into shock, with symptoms like dizziness, pale, clammy skin or passing out. Increlex can also cause reactions at the injection site including: loss of fat (lipoatrophy); increase of fat (lipohypertrophy); pain; redness; or bruising.
Increased pressure in the brain (intracranial hypertension).
Increlex , like growth hormone, can sometimes cause a temporary increase in pressure within the brain. Symptoms include persistent headache and nausea with vomiting.
Enlarged tonsils.
Signs include: snoring, difficulty breathing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle-ear.
A bone problem called slipped capital femoral epiphysis.
When the top of the upper leg bone (femur) slips apart. This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help for your child right away if your child develops a limp or has hip or knee pain.
Worsened scoliosis.
(caused by rapid growth).
Tumor growths.
Several cases of cancerous tumors have been observed in children who received Increlex . Tell your doctor immediately if your child develops any new growths or symptoms of cancer.
Benzyl alcohol toxicity.
Benzyl alcohol, a preservative in Increlex , can cause serious side effects, including death in infants.
The most common side effects of Increlex include: Low blood sugar (hypoglycemia); injection site reactions; allergic reactions; and enlarged tonsils.
These are not all the side effects of Increlex . Call your child’s doctor if your child has side effects that are bothersome or that do not go away. You may report side effects to FDA at 1-800-FDA-1088.
How Should My Child Receive Increlex ?
The dose of Increlex to be given per injection can vary for each child. Your child’s doctor will determine the appropriate dose by taking into account your child’s weight, height, age, and other factors, such as tolerability. This information will be given to you, along with exact instructions and a dosing sheet.
A summary of how your child should receive Increlex is given here. Detailed Increlex injection instructions can be found in the Patient Information Leaflet and Instructions for Use.
Important Safety Information
Always give INCRELEX exactly as your doctor directed.
Do not take INCRELEX if you are allergic to IGF-1 or any of its other ingredients. Report any allergic reactions.
INCRELEX should be injected under the skin (subcutaneous injection). It should not be injected directly into a blood vessel.
INCRELEX should not be used after growth plates close which happens during puberty.
INCRELEX should not be used in children with cancerous tumors or a history of cancer.
Hypoglycemia (low blood sugar): INCRELEX should be administered 20 minutes before or after a meal or snack and should not be administered when the meal or snack is skipped.
Checking blood glucose levels is recommended. The dose of INCRELEX may need to be adjusted until an appropriate dose is decided by your doctor.
Intracranial Hypertension: Increased pressure in your skull may occur because of cerebrospinal fluid buildup around your brain. Therefore, your doctor may require an eye examination at the start of INCRELEX treatment and periodically during the time you are taking INCRELEX.
Lymphoid Tissue Hypertrophy: Lymphoid tissue hypertrophy is a noncancerous increase in the number of immune cells called lymphocytes. Patients should have periodic examinations with your doctor to rule out potential complications.
Slipped Capital Femoral Epiphysis: Slipped capital femoral epiphysis is a bone problem where the top of the upper leg (femur) slips apart. This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help for your child right away if your child develops a limp or has hip or knee pain.
Progression of Scoliosis: Your doctor will monitor you during treatment with INCRELEX if you have a history of scoliosis.
Malignant Neoplasia: There have been reports of cancerous tumors in children who received INCRELEX. It is unknown whether there is any relationship between INCRELEX therapy and new occurrence of tumors. Tumors were mostly reported in patients with rare genetic conditions of short stature associated with a higher risk of cancer, or in patients already at risk of cancer.
The tumors were seen more frequently in patients who received INCRELEX at higher than recommended doses or at doses that produced IGF-1 levels above normal for age and sex. Your doctor will carefully monitor you during your treatment with INCRELEX for development of tumors. If cancerous tumors develop, your doctor will stop your INCRELEX treatment.
Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preserved Solution: Serious and fatal adverse reactions can occur in neonates and infants treated with benzyl alcohol-preserved drugs. Use of INCRELEX in infants is not recommended.
The most common adverse reactions include low blood sugar, reactions at the injection site or throughout your body, and enlarged tonsils.
You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/medwatch
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