Tev-Tropin

Name: Tev-Tropin

What should i avoid while using somatropin?

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Manufacturer

  • Gate Pharmaceuticals

  • Teva Select Brands

Uses For Tev-Tropin

Somatropin 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 hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Noonan syndrome, Turner syndrome, short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age.

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

Pharmacokinetics

Following intravenous administration of 0.1 mg/kg of Tev-Tropin®, the elimination half-life was about 0.42 hours (approximately 25 minutes) and the mean plasma clearance (±SD) was 133 (±16) mL/min in healthy male volunteers.

In the same volunteers, after a subcutaneous injection of 0.1 mg/kg Tev-Tropin® to the forearm, the mean peak serum concentration (±SD) was 80 (±50) ng/mL which occurred approximately 7 hours post-injection and the apparent elimination half-life was approximately 2.7 hours. Compared to intravenous administration, the extent of systemic availability from subcutaneous administration was approximately 70%.

Adverse Reactions

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

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 influences 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 Tev-Tropin® with the incidence of antibodies to other products may be misleading. With respect to growth hormone, antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases, when binding capacity exceeds 2 mg/L, growth attenuation has been observed.

None of the patients with anti-GH antibodies in the clinical studies experienced decreased linear growth response to Tev-Tropin® or any other associated adverse event. Injection site reactions (e.g., pain, bruise) occurred in 8 of the 164 treated patients.

Leukemia has been reported in a small number of patients treated with other growth hormone products. It is uncertain whether this 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.

New-onset type 2 diabetes mellitus has been reported.

Overdosage

The recommended dosage of up to 0.1 mg/kg of body weight 3 times per week should not be exceeded. Acute overdose could cause initial hypoglycemia and subsequent hyperglycemia. Repeated use of doses in excess of those recommended could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess human growth hormone.

Stability and storage

Before Reconstitution
Vials of Tev-Tropin® (5 and 10 mg) are stable when refrigerated at 36° to 46°F (2° to 8°C). Avoid freezing the accompanying diluent. Expiration dates are stated on the labels.

After Reconstitution
Tev-Tropin® 5 mg is stable for up to 14 days when reconstituted with bacteriostatic 0.9% sodium chloride (normal saline), USP, and stored in a refrigerator at 36° to 46°F (2° to 8°C). Do not freeze the reconstituted solution.

Tev-Tropin® 10 mg is stable for up to 28 days when reconstituted with 1 mL syringe of bacteriostatic water for injection containing 0.33% metacresol as a preservative, and stored in a refrigerator at 36° to 46°F (2° to 8°C). Do not freeze the reconstituted solution.

PACKAGE LABEL - DILUENT 5mL LABEL

NDC 57844-103-33

Bacteriostatic 0.9% Sodium Chloride Injection, USP (Benzyl Alcohol Preserved)

NOT FOR USE IN NEWBORNS

NOT FOR INHALATION

GATE Rx only

5 mL

For Subcutaneous Use Only.

Each vial contains: 0.9% sodium chloride, 09.% benzyl alcohol, and Water for Injection, USP.

Refrigerate at 2° to 8°C (36° to 46°F).

Manufactured In Israel

Distributed By:

GATE PHARMACEUTICALS

div. TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 9/2004               0082-6008v2

Lot No.:

Exp. Date:

PACKAGE LABEL - DILUENT 1mL LABEL

NDC 57844-102-21

Bacteriostatic Water for Injection

containing 0.33% metacresol as an antimicrobial preservative

For Reconstitution Use Only.      Rx only

1 mL

Lot No.:

Exp Date:

NDC 57844-102-21

Bacteriostatic Water for Injection

containing 0.33% metacresol as an antimicrobial preservative

For Reconstitution Use Only.      Rx only

1 mL

Manufactured In Germany

Distributed By:

TEVA Biologics & Specialty Products
Horsham, PA 19044

0082-XXXv1      Rev. A X/XXXX

For the Consumer

Applies to somatropin: powder for solution

Other dosage forms:

  • powder for solution, solution

Along with its needed effects, somatropin (the active ingredient contained in Tev-Tropin) 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 while taking somatropin:

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 while taking somatropin:

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 of somatropin 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

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