Zomacton 5 mg

Zomacton(somatropin) is an injectable medication approved by the U.S. Food and Drug Administration (FDA) for treating adults and children who have a deficiency of growth hormone. A lack of growth hormone can cause a variety of symptoms, including short stature in children and weight fluctuations in adults. zomacton 5 mg 

Growth hormone is produced in the pituitary gland , a tiny gland located in the brain. The hormone is released into the blood and flows throughout the body, where it activates a number of cellular functions, such as bone and muscle growth and physical repair.

A growth hormone deficiency can lead to metabolic problems for adults, and it can cause slow growth and short stature in children. Blood tests can be used to measure the hormone and can help determine the cause of a deficiency.

Zomacton,which is produced using a human growth hormone gene, binds to cells in the body at the same binding site where growth hormone would normally bind. The medication then works to imitate the actions of growth hormone, stimulating a variety of cellular activities. For example, it mediates glucose and fat metabolism and it regulates proteins that speed up muscle and skin growth and lengthen the bones in growing children.

Growth hormone deficiency: Zomactoncan be use to treat slow growth or inadequate growth due to a deficiency of naturally produced growth hormone.

Turner syndrome: It is used for treating children who are shorter than expected due to Turner syndrome . This syndrome is a chromosomal defect in which girls have only one X chromosome instead of two X chromosomes. Girls who have Turner syndrome experience slow development and other developmental issues, such as delayed puberty and infertility or diminished fertility.

Short stature homeobox-

containing gene (SHOX) deficiency: SHOX is a genetic condition in which a mutation on the X or Y chromosome results in developmental problems. It can affect boys or girls.

Small size at birth: Zomactonis approve for treating children who are short in stature because they were born small for gestational age (SGA) and didn’t catch-up on their growth by the age of 2 to 4 years old.

Head trauma, a pituitary tumor, an infection in the brain, or a bleed in the brain can all damage the pituitary gland. Tumors such as craniopharyngioma and pituitary adenoma can have varied prognosis.

ces growth hormone, and it is not medically recommended for off-label use for conditions without a confirmed growth hormone deficiency.

This medication can exacerbate certain medical conditions. You should not use Zomactonif you have already had an allergic reaction to somatropin in the past. Because it is a hormone that has many effects, including effects on growth and metabolism, it may have an impact on several medical conditions.

If you already take Zomactonor are going to start, you should talk to your healthcare provider if you develop a severe illness, such as an infection.

Children and adults who have cancer or who recovered from cancer can have growth or recurrence of cancer in association with Zomacton,and close monitoring can help identify signs of cancer progression.

Caution and Monitoring

When using this medication, you will have some monitoring of the potential effects of growth hormone.

Glucose levels : Your glucose levels should be monitored because this medication can decrease your insulin sensitivity, especially if you already have glucose intolerance or diabetes mellitus.

Thyroid function : This medication can increase the risk of hypothyroidism (low thyroid function). This is a high risk for people who already have hypothyroidism or for women (who have or don’t have a diagnosis of hypothyroidism).

Cortisol levels : People who have hypoadrenalism (low adrenal function) can develop reduced serum cortisol levels and/or may need to use a higher dose of glucocorticoids due to the effects of Zomacton.

Scoliosis : Children who have scoliosis (an abnormal curve of the spine) may experience progression of the condition as a result of taking Zomacton.

Contraindications

This medication can cause serious problems in people who have certain medical conditions. According to the manufacturer, children who already have closed bone epiphysis (the bone growth has reached full completion) should not use Zomacton.

Children who have Prader-Willi syndrome (a genetic disorder) and have obesity or breathing problems have a risk of sudden death when taking this medication.

According to the manufacturer, people who have active cancer should not take Zomacton.And the manufacturer warns against taking this medication if you have diabetic retinopathy (a disease of the eye caused by diabetes)

Zomactonis injected subcutaneously (under the skin). It can be injected into the back of the upper arm, abdomen, buttock, or thigh. The injection location should be changed following a rotating schedule rather than using the same area for more than one injection in a row. This allows the area to heal and helps prevent issues like tenderness or soreness

Mean chronological age at baseline was 9 ± 0.9 years (range: 7 to 11). Additional study entry criteria included birth length SDS <-2 or <3rd percentile for gestational age, and height SDS for chronological age <-2. Exclusion criteria included syndromal conditions (e.g., Turner syndrome), chronic disease (e.g., diabetes mellitus), and any active disease. All 35 patients completed the study. Mean height SDS increased from a baseline value of -2.7 (SD 0.5) to -1.5 (SD 0.6) after 2 years of treatment.

Adult Patients With Growth Hormone Deficiency

Two studies in patients with adult-onset GH deficiency (total n=98) and two studies in adult patients with childhood-onset GH deficiency (total n=67) were design to assess the effects of replacement therapy with another somatropin product. Adult-onset patients and childhood-onset patients differ by diagnosis (organic vs. idiopathic pituitary disease), body size (average vs. small [mean height and weight]), and age (mean 44 vs. 29 years). These four studies each include a 6-month randomized, blinded, placebo-

controlled phase, during which approximately half of the patients receive placebo injections, while the other half receive injections with another somatropin product. The 6-month, double-blind phase was follow by 12 months of open-label somatropin treatment for all patients. The dosages of this other somatropin product for all studies were identical: 1 month of treatment at 0.00625 mg/kg/dayfollow by 0.0125 mg/kg/dayfor the next 5months. The primary efficacy measures were body composition (lean body mass and fat mass) and lipid parameters. Lean body mass was determine by bioelectrical impedance analysis (BIA), validated with potassium 40.

In patients with adult-onset GH deficiency, treatment with another somatropin product (vs. placebo) resulted in an increase in mean lean body mass (2.59 vs. -0.22 kg, p<0.001) and a decrease in body fat (-3.27 vs. 0.56 kg, p<0.001). Similar changes were seen in childhood-onset GH deficient patients. Changes in lean body mass persisted throughout the 18-month period for both the adult-onset and childhood-

onset groups; the changes in fat mass persisted in the childhood-onset group. Serum concentrations of high-density lipoprotein (HDL) cholesterol which were low at baseline (mean, 30.1 mg/mLand 33.9 mg/mLin adult-onset and childhood-onset patients, respectively) had normalized by the end of 18 months of treatment with this other somatropin product (mean change of 13.7 mg/dLand 11.1 mg/dLfor the adult-onset and childhood-onset groups, respectively p<0.001).

Medication Guide

(zoh-MACK-ton)

[somatropin] for Injection

Read the Instructions for Use that come with your ZOMACTON®before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Before you use ZOMACTONfor the first time, make sure your healthcare provider shows you the right way to use it.

Supplies needed for your ZOMACTONInjection

Figure A

ZOMACTON5mg (See Figure A) containing:

1 vial of ZOMACTON5mg growth hormone in a powder

1 vial of liquid (diluent) containing Bacteriostatic 0.9% Sodium Chloride Injection, USP (5mL). This is use to mix your ZOMACTON5mg.

ZOMACTON10mg (See Figure B) containing:

1 vial of ZOMACTON10mg growth hormone in a powder

1 syringe of liquid (diluent) containing Bacteriostatic Water for Injection with 0.33% Metacresol as a preservative (1 mL). This is use to mix your ZOMACTON10mg.

25 gauge mixing needle

Figure B

The following additional supplies (See Figure C) will be need:

Syringe and needle for injection. Your healthcare provider will tell you the size of the syringe and needle to use

Remove the hard plastic cap from the top of the liquid vial by gently pushing up on the edge of the cap (See Figure D). Do not remove the rubber stopper.

Use an alcohol swab to wipe off the top of the liquid vial (See Figure E). After cleaning, do not touch the rubber stopper.

Remove the needle cap from the syringe while making sure you do not touch the needle (See Figure F). Do not throw away the needle cap.

Hold the barrel of the syringe with 1 hand and pull back on the plunger with the other hand until you have drawn up the amount of air that is the same as the amount of liquid your healthcare provider has prescribed (See Figure G).

Insert the needle into the liquid vial through the center of the clean rubber stopper. Push down on the plunger until all the air is release into the vial (See Figure H).

Hold the vial with 1 hand and carefully turn the vial upside down, making sure the syringe needle stays in the vial. The tip of the needle should be below the surface of the liquid.

With your other hand, gently pull back the plunger until the amount of liquid your healthcare provider prescribed is in the syringe (See Figure I).

Figure I

When the syringe is correctly fill with the liquid, remove the syringe and needle from the vial and recap the needle.

Preparing ZOMACTON10mg Liquid for Injection:

Remove the syringe tip cap from the top of the pre-filled liquid syringe and attach the 25G mixing needle that comes with your ZOMACTON(See Figure J).

Figure J

Figure M

Figure N

Step 1: Preparing the Injection

You are now ready for your ZOMACTONinjection.

Figure O

Figure R

Wash your hands thoroughly with soap and water.

Check that the vial of growth hormone you are using is clear and that the date of mixing is within 14 days if you are using ZOMACTON5mg or 28 days if you are using ZOMACTON10mg.

Clean the top of the growth hormone vial with an alcohol swab. Do not touch the rubber stopper after cleaning (See Figure O).

Remove the needle cap from the syringe and insert the needle into the center of the rubber stopper on the growth hormone vial (See Figure P).

Gently pull back the plunger until the amount of growth hormone solution your healthcare provider has prescribed is in the syringe (See Figure Q).

Remove the needle from the vial when the syringe is correctly fill with the solution (See Figure R). Recap the needle.

Step 2: Choosing an Injection Site

Figure S

If you notice any of the following signs, contact your healthcare provider:

There are different sites you can use for your injections. These sites should be rotate (See Figure S).

A lump, bruise or redness at the injection site that does not go away.

Any sign of infection at the injection site ( pus , redness, heat or persistent pain).

Severe, sharp pain or ache at injection site that does not go away.