Take a Second Look at HIV-associated Wasting

Be Aware of HIV-associated wasting

The impact on patients can be serious.

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The pathophysiology of HIV-associated wasting is multifactorial.3,4,5

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Discover the science

For over 10 years, Serostim® [somatropin (rDNA origin) for injection] has helped treat patients.

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Serostim® is proven to increase weight and lean body mass and improve physical endurance.2,6

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Supporting your patients

The AXIS Center offers your patients reimbursement support for Serostim® [somatropin (rDNA origin) for injection].

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Tracking outcomes can help patients reach treatment goals.

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Access the full prescribing information.


References:

  1. Castaneda C. Muscle wasting and protein metabolism. J Anim Sci. 2002;80(E Suppl. 2):E98-E105.
  2. Serostim® [somatropin (rDNA origin) for injection] Prescribing Information. Rockland, MA: EMD Serono; 2014.
  3. Roubenoff R, Grinspoon S, Skolnik PR, et al. Role of cytokines and testosterone in regulating lean body mass and resting energy expenditure in HIV-infected men. Am J Physiol Endocrinol Metab. 2002;283:E138-E145.
  4. Dudgeon WD, Phillips KD, Carson JA, et al. Counteracting muscle wasting in HIV-infected individuals. HIV Med. 2006;7:299-310.
  5. Grinspoon S, Corcoran C, Stanley T, et al. Effects of androgen administration on the growth hormone-insulin-like growth factor I axis in men with acquired immunodeficiency syndrome wasting. J Clin Endocrinol Metab. 1998;83:4251-4256.
  6. Moyle GJ, Daar ES, Gertner JM, et al. Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;35:367-375.
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Important Risk Information and Indication Toggle Button

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Acute Critical Illness:
Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure.

Active Malignancy:
In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity.

Diabetic Retinopathy:
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Hypersensitivity:
Serostim® is contraindicated in patients with a known hypersensitivity to somatropin or diluent.

WARNINGS AND PRECAUTIONS

Concomitant Antiretroviral Therapy:
In some experimental systems, somatropin has been shown to potentiate HIV replication in vitro at concentrations ranging from 50-250 ng/ml. However, the protocols required all participants to be on concomitant antiretroviral therapy for the duration of the controlled clinical trials, with no significant somatropin-associated increase in viral burden observed. In view of the potential for acceleration of virus replication, it is recommended that HIV patients be maintained on antiretroviral therapy for the duration of Serostim® treatment.

Impaired Glucose Tolerance/Diabetes:
Hyperglycemia may occur in HIV infected individuals due to a variety of reasons. Patients with other risk factors for glucose intolerance should be monitored closely during Serostim® therapy.
Cases of new onset impaired glucose tolerance, new onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim®. Some patients developed diabetic ketoacidosis and diabetic coma. In some patients, these conditions improved when Serostim was discontinued, while in others, the glucose intolerance persisted. Some of these patients required initiation or adjustment of antidiabetic treatment while on Serostim®.

Intracranial Hypertension:
Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin products. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved.

Fluid Retention/Carpal Tunnel Syndrome:
Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim®, but may resolve spontaneously, with analgesic therapy, or after reducing the frequency of dosing.
Carpal tunnel syndrome may occur during treatment with Serostim®. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim®, it is recommended that treatment be discontinued.

Local and Systemic Reaction:
Injection site should be rotated to avoid tissue atrophy. Patient should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur.

Neoplasms:
Because malignancies are more common in HIV positive individuals, the risks and benefits of starting somatropin in HIV positive patients should be carefully considered before initiating Serostim® treatment and patients should be monitored carefully for the development of neoplasms if treatment with somatropin is initiated.
Monitor all patients with a history of any neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor and for increased growth, or potential malignant changes of preexisting nevi.

Pancreatitis:
Cases of pancreatitis have been reported rarely in adults. Pancreatitis should be considered in any somatropin–treated patient who develops abdominal pain.

Controlled Clinical Trial 2 Adverse Reactions Occurring in at least 5% of Patients in one of the Treatment Groups, and at an Incidence Greater than Placebo

Placebo 0.1 mg/kg every other day Serostim® 0.1 mg/kg daily Serostim®
Patients
(n=247)
Patients
(n=257)
Patients
(n=253)
Body System
Preferred Term
% % %
Musculoskeletal System Disorders
Arthralgia 11.3 24.5 36.4
Myalgia 11.7 17.9 30.4
Arthrosis 3.6 7.8 10.7
Gastrointestinal System Disorders
Nausea 4.9 5.4 9.1
Body As A Whole - General Disorders
Edema Peripheral 2.8 11.3 26.1
Fatigue 4.5 3.5 5.1
Endocrine Disorders
Gynecomastia 0.4 3.5 5.5
Central and Peripheral Nervous System Disorders
Paresthesia 4.5 7.4 7.9
Hypoesthesia 2.4 1.6 5.1
Metabolic and Nutritional Disorders
Edema Generalized 1.2 1.2 5.9

ADVERSE REACTIONS

In clinical trials in HIV-associated wasting or cachexia the most common adverse reactions included (incidence >10%) peripheral edema and musculoskeletal disorders (arthralgia, myalgia, arthrosis).

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INDICATION

Indications and Usage
Serostim® [somatropin (rDNA origin) for injection] is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

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