Description
Mecasermin injection is a man-made version of insulin-like growth factor-1 (IGF-1) hormone. IGF-1 is produced in the liver and plays an important role in childhood growth. Mecasermin is used to replace IGF-1 in children who are severely lacking it in their bodies or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in the geriatric population. Safety and efficacy have not been established.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer, or history of or
- Closed epiphyses (normal bone growth stopped)—Should not be used in patients with these conditions.
- Diabetes or
- Enlarged tonsils or
- Head injury or
- Scoliosis (abnormally curved spine), or history of—Use with caution. May make these conditions worse.
- Hypothyroidism (underactive thyroid) or
- Nutrition deficiencies—These problems should be corrected first before starting treatment with mecasermin.
Proper Use
Your child's doctor will prescribe your child's exact dose and tell you how often it should be given. This medicine is given as a shot under the skin of your child's stomach, thigh, upper arm, or buttocks. This medicine must not be injected into a vein or muscle.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your child's doctor if you have any questions.
This medicine may be given at home to patients who do not need to be in the hospital. If your child is using this medicine at home, your child's doctor will teach you or your child's caregiver how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.
Use a different body area each time you give your child an injection. Keep track of where you give each injection to make sure you rotate body areas. This will help prevent skin problems from the injections.
This medicine must be taken 20 minutes before or 20 minutes after a snack or meal. Do not let your child skip a meal after receiving this medicine.
To use the vial:
- Wash your hands with soap and water before and after using this medicine.
- Check the liquid in the vial. It should be clear and colorless. Do not use it if it is cloudy or has particles in it.
- Remove the protective cap. Do not remove the rubber top.
- Pull back on the plunger to draw air into the syringe equal to the prescribed dose. Put the needle through the rubber top of the vial and push the plunger to inject air into the vial.
- Leave the syringe in the vial and turn both upside down. Hold it firmly.
- Make sure the tip of the needle is in the liquid. Pull the plunger to withdraw the correct dose into the syringe.
- Before removing the needle out of the vial, check the syringe for air bubbles. If there are bubbles in the syringe, hold the vial and syringe with the needle straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw liquid back in until you have the correct dose.
- Remove the needle from the vial. Do not let the needle touch anything.
- Pinch the skin and insert the needle. Slowly push the plunger of the syringe all the way in to make sure you have injected all of the liquid. Pull the needle straight out and gently press on the injection site with gauze or a cotton ball for a few seconds.
- Use a new needle and syringe each time you inject the medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (vial):
- For treatment of growth failure caused by IGF-1 deficiency:
- Children 2 years of age and older—Dose is based on body weight and must be determined by your child's doctor. The starting dose is 0.04 to 0.08 milligram (mg) per kg of body weight injected under the skin 2 times a day. The doctor may increase the dose, as needed. However, the dose is usually not more than 0.12 mg per kg of body weight 2 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your child's doctor.
- For treatment of growth failure caused by IGF-1 deficiency:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may store the opened vial in the refrigerator. Use it within 30 days after opening. Throw away any unused medicine after 30 days. Do not freeze.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
Your child's doctor will need to check your child's progress at regular visits while your child is using this medicine. Be sure to keep all appointments.
Talk with your child's doctor if you notice, or the child feels, that this medicine is causing too much growth.
This medicine may cause hypoglycemia (low blood sugar). Symptoms include: anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. It is important to have a source of sugar including orange juice, candy, soda, glucose gel, or milk, if these symptoms occur.
Learn what to do if your child's blood sugar gets too low. Teach family members and friends what they can do to help if your child has low blood sugar.
Your child should avoid participating in high risk activities, including driving, within 2 to 3 hours after receiving the medicine, especially at the beginning of mecasermin treatment.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your child's doctor right away if your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth after receiving this medicine.
This medicine may cause intracranial hypertension (increased pressure in the head). Check with your child's doctor right away if your child has blurred vision, change in ability to see colors, especially blue or yellow, headache, or nausea and vomiting.
This medicine may enlarge your child's tonsils. Call your child's doctor right away if your child has swollen tonsils, snoring, trouble with breathing or swallowing, or fluid in the ear. The doctor may want to check your child's tonsils regularly while using this medicine.
This medicine may cause a dislocation in the hip bone. Check with your child's doctor right away if your child has a limp or pain in the hip or knee.
Using this medicine may increase your child's risk of getting cancer. Talk to your child's doctor if you have concerns about this risk.
This medicine contains benzyl alcohol which may cause serious reactions (eg, gasping syndrome) for a newborn or premature infant. Discuss this with your child's doctor if you are concerned.
Do not give your child other medicines unless they have been discussed with your child's doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Anxiety
- bluish skin color of the fingertips
- blurred vision
- breathlessness
- chest pain
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- depression
- dizziness
- fast heartbeat
- headache
- increased hunger
- loss of hearing
- nausea
- nervousness
- nightmares
- rapid growth of normal cells of the thymus (no symptoms)
- seizures
- shakiness
- slurred speech
- thickening of the skin
- unusual tiredness or weakness
Incidence not known
- Change in the ability to see colors, especially blue or yellow
- chest tightness
- cough
- difficult or labored breathing
- difficulty with swallowing
- hives or welts, itching, or skin rash
- itching or hives at the injection site
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- limp
- pain in the hip or knee
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- arm or leg pain
- backache
- changes in vision
- excessive sweating
- extreme weakness
- frequent urination
- increase in hands and feet size
- increased thirst
- increased volume of pale, diluted urine
- joint pain
- stop in menstruation
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abnormal response of the tympanic membrane to air pressure
- difficulty with moving
- difficulty with swallowing
- ear pain
- earache
- large, flat, blue or purplish patches in the skin
- muffled hearing
- muscle pain or stiffness
- redness or swelling in the ear
- sense of fullness in the ear
- snoring
- sore throat
- voice changing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20068117
