Saizen

Saizen is a prescription medicine used to treat the symptoms of Growth Hormone Deficiency. Saizen may be used alone or with other medications. Saizen belongs to a class of drugs called Growth Hormone Analogs. What are the possible side effects of Saizen?Saizen

Saizen may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• shortness of breath,
• coughing,
• new or increased snoring,
• pain in your knees or hips,
• walking with a limp,
• ear pain,
• swelling, warmth or drainage from the ear,
• numbness or tingling in your wrist, hand, or fingers,
• severe swelling or puffiness in your hands and feet,
• changes in behavior,
• vision problems,
• unusual headaches,
• changes in the shape or size of a mole,
• pain or swelling in your joints,
• severe pain in your upper stomach spreading to your back,
• nausea,
• vomiting,
• increased thirst,
• increased urination,
• dry mouth,
• fruity breath odor,
• severe headaches,
• ringing in your ears,
• dizziness,
• vision problems,
• pain behind your eyes,
• extreme weakness,
• weight loss,
• changes in skin color, and
• tiredness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Saizen include:

• pain, itching, or skin changes where the medicine was injected,
• swelling,
• rapid weight gain,
• muscle or joint pain,
• numbness or tingling,
• stomach pain,
• gas,
• headache,
• back pain,
• cold or flu symptoms,
• stuffy nose,
• sneezing,
• sore throat, and
• ear pain

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Saizen. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

SAIZEN is a human growth hormone produced by recombinant DNA technology. SAIZEN 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. SAIZEN is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene.

SAIZEN is a sterile, non pyrogenic, white, lyophilized powder intended for subcutaneous injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.

Vials

SAIZEN is available in 5 mg and 8.8 mg vials. The quantitative composition per vial is:

5 mg vial

Each vial contains 5.0 mg somatropin, 34.2 mg sucrose and 1.16 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosp