Somatropin, mammalian derived

Generic name: Somatropin, Mammalian Derived
Drug class: Growth hormones

Usage of Somatropin, mammalian derived

Somatropin injection is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth failure caused by growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), or Turner syndrome.

Somatropin injection is also used together with a proper diet to treat short bowel syndrome (SBS), which is a condition that prevents the intestine or gut from absorbing food properly.

This medicine is available only with your doctor's prescription.

Somatropin, mammalian derived 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

Abnormal or decreased touch sensation

bleeding after defecation

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in skin color

cold flu-like symptoms

cold hands and feet

confusion

constipation

cough or hoarseness

darkened urine

decreased urination

diarrhea

difficult urination

dizziness

dry mouth

fainting or loss of consciousness

fast heartbeat

fast or irregular breathing

feeling unusually cold

fever or chills

full or bloated feeling

general feeling of discomfort or illness

headache

increase in heart rate

itching or skin rash

joint pain

light-colored stools

lightheadedness

loss of appetite

lower back or side pain

muscle aching or cramping

muscle pain or stiffness

nausea

pain

pain, redness, or swelling in the arm or leg

pains in the stomach, side, or abdomen, possibly radiating to the back

pressure in the stomach

rapid, shallow breathing

rapid weight gain

rectal bleeding

runny nose

shivering

sneezing

sore mouth or tongue

sore throat

stomach bloating, burning, cramping, or pain

sudden decrease in the amount of urine

sweating

swelling of the abdominal or stomach area

swelling of the eyes or eyelids

swelling or puffiness of the face

swollen joints

thirst

tightness in the chest

tingling of the hands or feet

trouble breathing

trouble sleeping

uncomfortable swelling around the anus

unpleasant breath odor

unusual tiredness or weakness

unusual weight gain or loss

vomiting

vomiting of blood

white patches in the mouth, tongue, or throat

wrinkled skin

yellow eyes or skin

Less common

Bone or skeletal pain

burning, numbness, pain, or tingling in all fingers except smallest finger

chest pain

depressed mood

dry skin and hair

feeling cold

hair loss

hoarseness or husky voice

slowed heartbeat

swelling of the ankles

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Anxiety

blurred vision

changes in vision

cold sweats

coma

cool, pale skin

decrease in the amount of urine

depression

excessive sweating

extreme weakness

flushed, dry skin

frequent urination

fruit-like breath odor

increase in hands and feet size

increased hunger

increased thirst

increased urination

increased volume of pale, diluted urine

nightmares

noisy, rattling breathing

pain in the arms or legs

seizures

shakiness

slurred speech

stop in menstruation

swelling of the fingers or hands

troubled breathing at rest

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

Body aches or pain

breast pain

change in the color, amount, or odor of vaginal discharge

congestion

discoloration of the fingernails or toenails

dryness or soreness of the throat

excess air or gas in the stomach or intestines

frequent urge to defecate

increased sweating

passing gas

sneezing

straining while passing stool

stuffy nose

tender, swollen glands in neck

trouble with swallowing

voice changes

Less common

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

tiredness

trouble concentrating

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.

Before taking Somatropin, mammalian derived

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin injection in children with growth hormone deficiency.

Appropriate studies have not been performed on the relationship of age to the effects of somatropin injection in children with short bowel syndrome. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin injection in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require an adjustment of dosage in patients receiving somatropin injection.

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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.

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How to use Somatropin, mammalian derived

This medicine is given as a shot under your skin or into a muscle. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

If you are using this medicine to treat short bowel syndrome, carefully follow your doctor's instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

There are many different forms (eg, vial, cartridge, injection device) available for this medicine. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medication. Also, read all instructions carefully to be sure you know how to use your device.

Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Use a new needle, unopened vial, or syringe each time you inject your medicine.

You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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:

For treatment of growth hormone deficiency:

Adults—

Nutropin® or Nutropin AQ®:

Non-weight based: At first, the usual dose is 0.15 to 0.3 milligrams (mg) injected under the skin once a day. Your doctor may adjust your dose if needed.

Weight-based: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.006 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 0.025 to 0.0125 mg per kg of body weight per day.

Saizen®: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.005 mg per kg of body weight injected under the skin once a day. Your doctor may adjust your dose if needed.

Children—

Nutropin® or Nutropin AQ®: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 to 0.7 mg per kg of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.

Saizen®: Dose is based on body weight and must be determined by your doctor. The usual dose is 0.06 mg per kg of body weight, given 3 times per week and injected under the skin or into a muscle. Your doctor may adjust your dose if needed.

For treatment of growth failure due to chronic kidney disease:

Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.

For treatment of idiopathic short stature:

Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.

For treatment of short bowel syndrome:

Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day for 4 weeks. Your doctor may adjust your dose if needed.

Children—Use and dose must be determined by your doctor.

For treatment of short stature with Turner syndrome:

Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into equal doses 3 to 7 times per week. Your doctor may adjust your dose if needed.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

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 unopened vials, cartridges, and injection devices of Nutropin® and Nutropin AQ® in the refrigerator, away from heat and direct light. Do not freeze.

Store unopened vials of Saizen® and Zorbtive® at room temperature, away from heat and direct light. Do not freeze.

Store the medicine that has been mixed in the refrigerator. The Nutropin® or Saizen® vials and Zorbtive® that has been mixed should be used within 14 days. The Saizen® click.easy® cartridge that has been mixed should be used within 21 days. Nutropin AQ® vial, cartridge, and injection device should be used within 28 days. Make sure you understand how long you can store the medicine after it has been mixed. Throw away any mixed medicine that has not been used within this time.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Warnings

It is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

This medicine may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee.

Pancreatitis (an inflamed pancreas) may occur while you are using this medicine. Check with your doctor right away if you or your child are having more than one of these symptoms: bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in stomach, side, or abdomen possibly radiating to the back, vomiting, or yellow eyes or skin.

This medicine may affect blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions.

This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child have burning, numbness, pain, or tingling in all fingers except smallest finger, swelling of the hands and feet, or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects.

This medicine is usually mixed with Bacteriostatic Water for Injection. You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to Benzyl Alcohol. If this is a concern, ask your doctor about other ways to mix this medicine.

Disclaimer

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