mecasermin
 Mecasermin

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Increlex, |mecasermin Mecasermin

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mecasermin

Generic Name: mecasermin (mec A sir men)
Brand Names: Increlex

What is mecasermin?

Mecasermin is man-made insulin-like growth factor-1 (IGF-1), which is the same as the IGF-1 made by your body. IGF-1 is important in the body for the growth of bones and muscles.

Mecasermin is used to treat growth failure in children whose bodies do not make enough IGF-1.

Mecasermin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about mecasermin?

In addition to this information, you should receive the specific mecasermin product instructions that show you how to inject the drug. Ask your doctor or pharmacist if you did not receive additional product instructions that show you how to inject mecasermin.

Use mecasermin exactly as directed by your doctor for your child. Your doctor or nurse should teach you how to inject mecasermin. Do not give your child mecasermin unless you understand all of the instructions.

What should I discuss with my healthcare provider before using mecasermin?

Your child should not take mecasermin if your child:

  • has finished growing (the bone growth plates are closed);

  • has cancer;

  • has other causes of growth failure;

  • is allergic to mecasermin or any of the inactive ingredients. Check with your child"s doctor if you are not sure.

Tell your child"s doctor about all of your child"s health conditions, including if your child:

  • has diabetes;

  • has kidney problems;

  • has liver problems; or

  • has a curved spine (scoliosis).

Tell your child"s doctor about all the medicines your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your child"s doctor if your child takes insulin or other anti-diabetes medicines. A dose adjustment may be needed for these medicines.

Mecasermin is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use mecasermin without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether mecasermin passes into breast milk. Do not use mecasermin without first talking to your doctor if you are breast-feeding a baby.

How should I use mecasermin?

In addition to this information, you should receive the specific mecasermin product instructions that show you how to inject the drug. Ask your doctor or pharmacist if you did not receive additional product instructions that show you how to inject mecasermin.

Use mecasermin exactly as directed by your doctor for your child. Your doctor or nurse should teach you how to inject mecasermin. Do not give your child mecasermin unless you understand all of the instructions.

Mecasermin should be injected subcutaneously (under the skin).

Inject mecasermin under your child"s skin shortly (20 minutes) before or after a meal or snack. Skip your child"s dose of mecasermin if your child cannot eat for any reason. Do not make up the missed dose by giving two doses the next time.

Inject mecasermin just below the skin in your child"s upper arm, upper leg (thigh), stomach area (abdomen), or buttocks. Never inject it into a vein or muscle. Change the injection site for each injection ("rotate the injection site").

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture resistant disposal container.

Only use mecasermin that is clear and colorless. If your child"s mecasermin is cloudy or slightly colored, return it for a replacement.

Store new unopened vials of mecasermin in the refrigerator (not the freezer) between 35 to 46F (2 to 8C). Do not freeze mecasermin. Keep mecasermin out of direct heat and bright light. If a vial freezes, throw it away.

Once a vial of mecasermin is opened, you can keep it in the refrigerator between 35 to 46F (2 to 8C) for 30 days after you start using the vial. Do not freeze mecasermin. Keep mecasermin out of direct heat and bright light. If a vial freezes, throw it away. Keep mecasermin and all medicines out of reach of children.

What happens if I miss a dose?

Inject mecasermin under your child"s skin shortly (20 minutes) before or after a meal or snack. Skip your child"s dose of mecasermin if your child cannot eat for any reason. Do not make up the missed dose by giving two doses the next time.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a mecasermin overdose are unknown but could include symptoms of low blood sugar such as shaking (tremor), cold sweats, increased hunger, headache, drowsiness, restlessness, irritability, weakness, trouble concentrating, dizziness, fast heartbeat, and nausea.

What should I avoid while using mecasermin?

Mecasermin may lower blood sugar levels like insulin. It is important to only give your child mecasermin right before or right after (20 minutes on either side of) a snack or meal to reduce the chances of low blood sugar. Do not give your child mecasermin if your child is sick or cannot eat.

Mecasermin side effects

Mecasermin may cause low blood sugar (hypoglycemia). Signs of low blood sugar are:

  • dizziness;

  • tiredness;

  • restlessness;

  • hunger;

  • irritability;

  • trouble concentrating;

  • sweating;

  • nausea; or

  • fast or irregular heartbeat.

Before beginning treatment with mecasermin your doctor or nurse will explain to you how to treat hypoglycemia. You or your child should always have a source of sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of hypoglycemia occur. For severe hypoglycemia, if your child is not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon. Your doctor or nurse will instruct you how to give the injection.

Severe hypoglycemia may cause unconsciousness, seizures, or death. People who take mecasermin, you should avoid participating in high risk activities (such as driving) within 2 to 3 hours after mecasermin injection, especially at the beginning of mecasermin treatment.

Mecasermin may enlarge your child"s tonsils. Some signs of enlarged tonsils include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle-ear. Sleep apnea can cause excessive daytime sleepiness. Call your doctor should these symptoms bother your child. Your doctor should do regular exams to check your child"s tonsils.

Mecasermin may cause a temporary increase in pressure within the brain. The symptoms can include headache and nausea with vomiting. Tell your doctor if your child has headache with vomiting. Your doctor can then check to see if this condition is present. If it is present, your doctor may decide to temporarily reduce or discontinue mecasermin therapy. Therapy may be started again later.

Mecasermin may cause a bone problem called "slipped capital femoral epiphysis". This happens when the top of the upper leg (femur) slips apart. Get medical attention for your child right away if your child develops a limp or has hip or knee pain.

Mecasermin may cause worsened scoliosis (caused by fast growth). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine.

Your child may have a mild or serious allergic reaction with mecasermin. Call your child"s doctor right away if your child gets a rash or hives. Get medical help immediately if your child has trouble breathing or goes into shock.

Mecasermin can cause reactions at the injection site including:

  • loss of fat (lipoatrophy);

  • increase of fat (lipohypertrophy); or

  • pain, redness, or bruising;

Injection site reactions can be avoided by changing the injection site at each injection. Call your child"s doctor if your child has side effects that are bothersome or that do not go away.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect mecasermin?

Mecasermin may affect blood sugar levels. It may be necessary to adjust the dosage of diabetes medications such as insulin, glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolbutamide (Orinase), and others.

Drugs other than those listed here may also interact with mecasermin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products

Where can I get more information?

  • Your pharmacist has additional information about mecasermin written for health professionals that you may read.

What does my medication look like?

Mecasermin is available with a prescription under the brand name Increlex. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ("Multum") is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum"s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum"s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 9/13/05 2:02:14 PM.



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