Saizen

Saizen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Saizen (somatropin [rDNA origin]) For Injection is a human growth hormone used to treat growth failure due to growth hormone deficiency. Common side effects of Saizen are joint pain, muscle pain, swelling, carpal tunnel syndrome, numbness, and burning,

The recommended weekly dosage of Saizen is 0.18 mg/kg of body weight divided into equal doses and taken either 3 alternate days, 6 times per week, or daily. Talk to your doctor about your individual dosage recommendation. Other replacement hormones, prednisone, corticosteroids, anticonvulsants, estrogen, and insulin may interact with Saizen. Tell your doctor all medications you use. If you have an acute critical illness only take Saizen if the potential benefit outweighs the risk. If you are pregnant only take Saizen if clearly needed. Exercise caution if you are breastfeeding and taking Saizen.

Our Saizen (somatropin [rDNA origin]) For Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Saizen in Detail - Patient Information: 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 somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;
  • 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, feeling tired;
  • redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;
  • pain in your arms or legs, joint stiffness or pain;
  • muscle pain; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Saizen (Somatropin Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Saizen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation, and may not reflect the adverse reaction rates observed in practice.

Growth Hormone Deficient Pediatric Patients

In clinical studies in which Saizen® was administered to growth hormone deficient children, the following reactions were infrequently seen: local reactions at the injection site (such as pain, numbness, redness and swelling), hypothyroidism, hypoglycemia, seizures, exacerbation of preexisting psoriasis and disturbances in fluid balance.

Growth Hormone Deficient Adult Patients

For a description of the clinical trials refer to section 14. During the 6-month placebo-controlled study, adverse reactions were reported in 56 patients (93.3%) in the somatropin-treated group and 42 patients (76.4%) in the placebo-treated group. Adverse reactions with an incidence of ≥ 5% in Saizen®-treated patients which were more frequent in Saizen®-treated patients compared with placebo-treated patients are listed in Table 1. Arthralgia, myalgia, peripheral edema, other types of edema, carpal tunnel syndrome, paraesthesia and hypoaesthesia were common in the somatropin-treated patients and reported more frequently than in the placebo group. These types of adverse reactions are thought to be related to the fluid accumulating effects of somatropin. During the placebo-controlled portion of the study, approximately 10% of patients without preexisting diabetes mellitus or impaired glucose tolerance treated with somatropin manifested mild, but persistent, abnormalities of glucose tolerance, compared with none in the placebo group. During the open label phase of the study, approximately 10% of patients treated with somatropin required a small upward adjustment of thyroid hormone replacement therapy for preexisting central hypothyroidism and 1 patient was newly diagnosed with central hypothyroidism. In addition, during the open label phase of the study, when all patients were being treated with somatropin, two patients with preexisting central hypoadrenalism required upward titration of hydrocortisone maintenance therapy which was considered to be suboptimal (unrelated to intercurrent stress, surgery or disease), and 1 patient was diagnosed de novo with central adrenal insufficiency after six months of somatropin treatment. Anti-GH antibodies were not detected.

Table 1 : Adverse Reactions with ≥ 5% Overall Incidence in Saizen®-Treated Patients Which Were More Frequent in Saizen®-Treated Patients Compared with Placebo-Treated Patients During a 6 Month Study

Adverse Reaction Saizen®-Treated
(N=60)
Placebo
(N=55)
Arthralgia 14 (23.3%) 7 (12.7%)
Headache 11 (18.3%) 8 (14.5%)
Edema peripheral 9 (15.0%) 2 (3.7%)
Myalgia 5 (8.3%) 2 (3.6%)
Paraesthesia 4 (6.7%) 1 (1.8%)
Hypoaesthesia 4 (6.7%) 0
Edema dependent 3 (5.0%) 2 (3.6%)
Skeletal Pain 3 (5.0%) 1 (1.8%)
Carpal tunnel syndrome 3 (5.0%) 1 (1.8%)
Edema generalized 3 (5.0%) 0
Chest pain 3 (5.0%) 0
Depression 3 (5.0%) 0
Hypothyroidism 3 (5.0%) 0
Insomnia 3 (5.0%) 0
N = number of patients

The adverse reaction pattern observed during the open label phase of the study was similar to the one presented above.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Saizen®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Leukemia has been reported in a small number of growth hormone deficient patients treated with growth hormone. It is uncertain whether this increased risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors. So far, epidemiological data fail to confirm the hypothesis of a relationship between growth hormone therapy and leukemia.

The following additional adverse reactions have been observed during the appropriate use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children and adults), (see WARNINGS AND PRECAUTIONS).

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Saizen® with the incidence of antibodies to other products may be misleading. In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.

Read the entire FDA prescribing information for Saizen (Somatropin Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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