Serostim

What is Serostim used for?

Serostim is a prescription medicine that is used to help patients with HIV gain weight. Serostim may be given to you for other reasons.

Description

SEROSTIM is a human growth hormone (hGH) produced by recombinant DNA technology. SEROSTIM has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. SEROSTIM is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. SEROSTIM is secreted directly through the cell membrane into the cell-culture medium for collection and purification.

SEROSTIM is a sterile lyophilized powder intended for subcutaneous injection after reconstitution to its liquid form.

Vials of SEROSTIM contain either 4 mg, 5 mg, or 6 mg. Each vial contains the following:

Each 4 mg multi-vial is supplied in a combination package with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.

Each 5 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution.

Each 6 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.

Mechanism of Action

SEROSTIM is an anabolic and anticatabolic agent which exerts its influence by interacting with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some, but not all of its effects, are mediated by insulin-like growth factor-1 (IGF-1).

Before taking Serostim, tell your doctor:

• If you are allergic to Serostim; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Breathing problems like sleep apnea; cancer or other tumors like a brain tumor; diabetic eye disease; or illness shortly after open heart surgery, stomach surgery, or accidental injury.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Serostim with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Serostim?

For all patients taking Serostim:

• Tell all of your health care providers that you take Serostim. This includes your doctors, nurses, pharmacists, and dentists.
• High blood sugar has happened with Serostim. This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Serostim.
• Have your eye pressure and eyesight checked as you have been told by the doctor.
• If you have cancer or a tumor or have ever had cancer or a tumor, talk with your doctor. The chance of cancer or tumor growth is raised with Serostim. The chance of new tumors may also be raised in some patients.
• If you have Turner syndrome, talk with your doctor. The chance of ear infections, high blood pressure, and very bad blood vessel problems like stroke and bleeding in the brain may be raised.
• Raised pressure in the head has rarely happened with Serostim. The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Signs most often happen within the first 8 weeks of starting Serostim. Call your doctor right away if you have change in eyesight, a very bad headache, upset stomach, or throwing up.
• If you are 65 or older, use Serostim with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Children:

• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. If you have questions, talk with the doctor.

How is Serostim best taken?

Use Serostim as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• If stored in a refrigerator, let Serostim come to room temperature before using it. Be sure you know how long to leave it at room temperature before using. Do not heat Serostim.
• Move the site where you give the shot with each shot.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not shake the solution.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Wash your hands before and after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Serostim.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Serostim that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• Sweating a lot.
• Depression or other mood changes.
• Change in how you act.
• Change in skin color.
• Burning, numbness, pain, or tingling in the hands, arms, legs, or feet.
• Bone pain.
• Change in color or size of a mole.
• Redness or swelling where the shot is given.
• Skin breakdown where Serostim is used.
• Ear pain.

What are some other side effects of Serostim?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling tired or weak.
• Back, muscle, or joint pain.
• Muscle stiffness.
• Trouble sleeping.
• Upset stomach or throwing up.
• Gas.
• Stomach pain or diarrhea.
• Irritation where the shot is given.
• Signs of a common cold.
• Flu-like signs.
• Hair loss.
• Enlarged breasts.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Serostim?

All products:

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Single-dose container:

• Use right away after mixing.

Multi-dose container:

• Use right away after mixing or you may store in a refrigerator for up to 2 weeks.

Label

PRINCIPAL DISPLAY PANEL – 4 MG KIT CARTON

PRINCIPAL DISPLAY PANEL – 5 MG KIT CARTON

• Serostim® 5 mg
  (somatropin) for injection
• 5 mg
  For subcutaneous injection
  Rx Only
• 7 vials SEROSTIM
  7 vials Sterile Diluent
• NDC 44087-0005-7
• EMD Serono

PRINCIPAL DISPLAY PANEL – 6 MG KIT CARTON

• Serostim® 6 mg
  (somatropin) for injection
• 6 mg
  For subcutaneous injection
  Rx Only
• 7 vials SEROSTIM
  7 vials Sterile Diluent
• NDC 44087-0006-7
• EMD Serono

SRC: NLM .