Accretropin

Generic Name: somatropin (rDNA origin)
Date of Approval: January 23, 2008
Company: Cangene Corporation
Treatment for: Pediatric Growth Hormone Deficiency; Turner Syndrome

FDA Approves Accretropin

The U.S. Food and Drug Administration has approved Accretropin (somatropin (rDNA origin)) Injection, a recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Accretropin is also indicated for the treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

Accretropin is identical in sequence to authentic human growth hormone of pituitary origin. Natural human growth hormone is a protein produced by the pituitary gland that acts on the ends of the long bones of the body (epiphyses) until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature.

Turner Syndrome is an X-chromosome-linked genetic disorder in girls that results in short stature and infertility.

Source: Cangene

Accretropin Consumer Information

What is Accretropin?

Accretropin is a form of human growth hormone.

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Accretropin is used to treat growth failure in children who lack natural growth hormone. Accretropin is also used for the treatment of short stature associated with Turner Syndrome in children.

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

If you use a steroid or any medicine to treat diabetes, your doses may need to be changed when you start using Accretropin. Do not stop using or change the dose of your steroid or diabetes medication without your doctor's advice.

Call your doctor at once if you have sudden and severe pain or tenderness in your upper stomach, with nausea, vomiting, sweating, fever, fast heartbeat, and yellowing of the skin or eyes. You should also call your doctor promptly if you have vision changes and sudden, severe pain behind your eyes.

Accretropin should be stored in the refrigerator. Avoid freezing and shaking. Do not use after expiration date stated on the vial and carton labels.

Once opened, Accretropin may be stored up to 14 days when refrigerated. Discard 14 days after first use. Protect from light.

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

Before you receive Accretropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine.

Do not use this medication if you are allergic to Accretropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);
  • cancer; or
  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use Accretropin if you have a serious medical condition after having:

  • open heart surgery or stomach surgery;
  • trauma or other medical emergency; or
  • breathing problems (such as lung failure).

Before using Accretropin, tell your doctor if you have:

  • liver disease;
  • kidney disease (or if you are on dialysis);
  • diabetes;
  • scoliosis;
  • high blood pressure (hypertension);
  • a pancreas disorder;
  • cancer (past or present);
  • carpal tunnel syndrome;
  • underactive thyroid; or
  • a brain tumor or lesion.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Accretropin.

FDA pregnancy category C. Accretropin may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Accretropin passes into breast milk or if it could harm a nursing baby. Do not use Accretropin without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I use Accretropin?

Use Accretropin exactly as it was prescribed for you. Do not use Accretropin in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your dose of this medicine and how often you give it will depend on what you are being treated for.

Accretropin is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

Your doctor or nurse will show you several areas on your body where you can inject Accretropin. Use a different injection place each time you give yourself the shot. Do not inject this medicine into skin that is red, sore, infected, or injured.

Do not shake the Accretropin vial (bottle). Vigorous shaking can ruin the medicine. Use a gentle swirling motion. Do not use the medication if it has changed colors or is cloudy. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested on a regular basis. Your eyes may also need to be checked. It is important that you not miss any scheduled visits to your doctor.

Accretropin should be stored in the refrigerator. Avoid freezing and shaking. Do not use after expiration date stated on the vial and carton labels.

Once opened, Accretropin may be stored up to 14 days when refrigerated. Discard 14 days after first use. Protect from light.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Symptoms of long-term overdose may include excessive growth.

Accretropin side effects

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use Accretropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • sudden and severe pain or tenderness in your upper stomach;
  • nausea, vomiting, sweating, fever, fast heartbeat, yellowing of the skin or eyes;
  • increased thirst and urination;
  • sudden and severe pain behind your eyes, vision changes;
  • swelling in your head, face, hands, or feet; or
  • numbness or tingling in your wrist, hand, or fingers.

Less serious side effects may include:

  • headache;
  • redness, soreness, swelling, skin rash, itching, pain, or bruising where the medicine was injected;
  • breast swelling;
  • joint pain, swelling, or stiffness; or
  • mild nausea, stomach pain, gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

See also: Side effects (in more detail)

What other drugs will affect Accretropin?

Before using Accretropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Accretropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Oral diabetes medicines include acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolazamide (Tolinase), and tolbutamide (Orinase). Do not change the dose of your diabetes medication without your doctor's advice.

Tell your doctor if you use any type of steroid medicine such as cortisone (Cortef, Cortone), methylprednisolone (Medrol), prednisone (Deltasone, Orasone), prednisolone (Prelone, Pediapred), and dexamethasone (Decadron). Steroids can make Accretropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.

This is not a complete list and there may be other drugs that can interact with Accretropin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Accretropin.

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