Accretropin
Generic Name: somatropin injection
Brand Name: Accretropin
What is Accretropin?
Acretropin is one of the forms that is a human form of growth hormone.
Acretropin is used for treating the problem of growth in children who do not have the natural growth hormone. The drug is also used for the treatment of the short stature that is associated with Turner Syndrome in children.¶
FDA Approves Accretropin
The U.S. Food and Drug Administration has approved Accretropin (somatropin (rDNA source)) Injection is a recombinant human hormone used to treat children who suffer from difficulty growing due to insufficient production of normal endogenous growth hormone. The Accretropin drug is also approved to treat the short stature that occurs by Turner Syndrome in pediatric patients whose epiphyses aren’t closed.
Acretropin is identical to the human growth hormone that is the pituitary source. Human growth hormones are a substance made by the pituitary gland. It affects the ends of bones that are long (epiphyses) until the beginning of puberty. It promotes the growth of normal size. Insufficient levels of this hormone in childhood cause abnormally small size.
Turner Syndrome is an X-chromosome-linked genetic condition in females that causes shorter size and infertility.
Source: Cangene
Precautions and warnings
If you take any steroid, or medication for treating diabetes the doses could need to be adjusted as you begin using Accretropin. Don’t stop taking or alter the dosage of your diabetes or steroid medication without consulting your physician.
Contact your doctor immediately If you experience extreme pain that is sudden or discomfort in your stomach, along with nausea vomiting, sweating, high fever, rapid heartbeat and the appearance of yellowing on your eyes or skin. It is also important to contact your doctor immediately for any changes in vision and sudden, intense eye pain.
The accretropin product should be kept within the fridge. Avoid shaking and freezing. Avoid using after the expiration dates are listed on the label of the carton and vial.
Once it is opened, Accretropin may be stored for up to 14 days refrigerated. Discard 14 days after first use. Be sure to keep away from light.
General
The treatment using Accretropin(somatropin injection) along with various other hormone preparations, must be supervised by doctors with experience in the management and diagnosis of children with GHD or Turner Syndrome (TS).
Somatropin treatment can decrease insulin sensitivity, especially at higher doses for vulnerable patients. This means that previously not diagnosed diminished the tolerance to glucose and even diabetic mellitus might be unveiled when taking somatropin.
Thus, the glucose levels should be checked frequently for all patients taking somatropin, in particular those who have the risk conditions of the development of diabetes mellitus such as for overweight (including obese patients with Prader-Willi-Syndrome), Turner Syndrome, or having a familial history for diabetes mellitus.
Patients who have an existing condition of Type-1 and type-2 diabetes, or impaired glucose tolerance need to be closely monitored during the treatment with somatropin. The dosages of antihyperglycemic medications (i.e. insulin or oral medications) could require adjustment when somatropin therapy begins in these patients.
Patients suffering from preexisting tumours, or a deficiency in growth hormone due to an intracranial lesion must be evaluated regularly to check for the advancement or the recurrence of the underlying process.
In children, research has not revealed any connection between somatropin replacement therapy as well as Central Nervous System ( CNS) tumour recurrence or the emergence of new additional tumours. However, there is a correlation between children who are tumour survivors the chance of developing a second tumour is reported for patients who received somatropin following their first cancer.
Intracranial tumours, particularly meningiomas in patients who were treated with radiotherapy toward the head in response to their first neoplasms are the most frequent of the second-stage tumours. In adulthood, it’s unclear if there is any connection between somatropin replacement therapy and CNS cancer recurrence.
The condition of intracranial hypertension (IH) with papilledema and headache, visual changes nausea and/or vomiting have been observed in a limited amount of patients treated with somatropin-based products. Symptoms typically occurred within the initial 8 weeks following the beginning of treatment with somatropin.
In all cases reported IH-related signs and symptoms quickly disappeared following the stopping therapy or reduction in the dose of somatropin. Funduscopic exams should be done frequently prior to initiating treatment with somatropin in order to rule out the presence of papilledema. It should also be performed regularly throughout the course of treatment. If papilledema is detected via funduscopy while receiving somatropin therapy it is recommended to stop treatment.
When somatropin-induced IH is identified and treated, somatropin treatment can be resumed at a lower dose once IH-related symptoms and signs are gone. Patients suffering from Turner Syndrome, Prader-Willi Syndrome or persistent kidney insufficiency are at a higher risk of developing IH.
For patients suffering from hypopituitarism (multiple hormone deficiencies), the standard hormone replacement therapy must be closely monitored whenever the treatment is given with somatropin.
Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children. Patients suffering from Turner Syndrome have an inherently higher chance of developing thyroid diseases that are autoimmune or secondary hypothyroidism.
For patients suffering from the deficiency of growth hormone primary (secondary) hypothyroidism can be first noticed or worsened after treatment with somatropin. Thus, patients taking somatropin must undergo periodic Thyroid function tests. Additionally, Thyroid hormonal replacement therapies should be started or adjusted as needed when necessary.
Patients must be watched carefully for any suspicious change in the skin lesions.
If somatropin is administered subcutaneously at the same location for a prolonged period of duration, tissue atrophy could result. This is preventable through rotation of the site.
As with all protein that is absorbed, locally or general allergic reactions could occur. Patients and parents must be aware that these reactions could be a possibility and that medical attention is required when allergic reactions are observed.
Pediatric Patients
A slipped capital femoral epiphysis can be more frequent in patients suffering from hormone-related issues (including GHD and Turner Syndrome) or those who are experiencing rapid growth. Any child with the first signs of limping and complaints about hip or knee discomfort in the course of somatropin therapy needs to be evaluated with care.
The progression in scoliosis may occur in patients experiencing rapid growth. Since somatropin can increase growth those with a history of scoliosis treated with somatropin must be closely monitored for the progress of scoliosis.
But, somatropin hasn’t been demonstrated to increase the likelihood of developing scoliosis. Skeletal abnormalities, including scoliosis, are often observed in patients who are not treated for Turner Syndrome patients. Scoliosis is also seen in patients who have not been treated for Prader-Willi Syndrome. Medical professionals should be aware of the abnormalities that may be present during treatment with somatropin.
Patients suffering from Turner Syndrome should be evaluated attentively for Otitis media and other hearing problems since they are more likely to develop hearing and ear problems. Treatment with somatropin can cause an increase in the frequency of Otitis media among patients suffering from Turner Syndrome. Additionally, patients suffering from Turner Syndrome must be observed closely for heart disorders (e.g. stroke, aortic aneurysm/dissection hypertension).
Adult Patients
The effectiveness and safety that are associated with Accretropin(somatropin injection) for adults have not been studied in clinical research.
Geriatric Use
The efficacy and safety of somatropin for patients 65 and over has not been examined in clinical research.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies on animal studies of carcinogenicity or mutagenicity as well as the impairment of fertility caused by Accretropin(somatropin injection) are not yet conducted.
Pregnancy
Classification of pregnancy C – Studies on animal reproduction have not been conducted using Accretropin(somatropin injection). It is unclear if Accretropin could cause harm to a fetus when given to a pregnant woman, or may affect fertility. Somatropin should be administered to pregnant women only when it is absolutely necessary.
Nursing Mothers
There are no studies done with Accretropin in nursing mothers. It is unclear if this substance is excreted from human milk. Since many drugs are excreted from human milk, it is important to be taken when somatropin is given to nursing mothers.
How to use Accretropin?
Utilize Accretropin exactly as prescribed to you. Don’t use Accretropin in greater quantities, or for longer than suggested by your physician. Follow the directions on the prescription label.
The dose you take of this medication and the frequency you administer it will be contingent on the condition you’re being treated for.
It is administered as an injection in the skin. The doctor, nurse or another healthcare professional will administer the injection. You might be given directions for how to administer your medication at your home. Avoid using this medicine at home if not know how to administer the injection and safely get rid of the needles and syringes utilized for administering the medicine.
The doctor or nurse will guide you through the various areas in your body where there is a place to inject Accretropin. You should choose a different location for your injection each time you administer the shot. Avoid injecting this medicine into skin that is swollen, red or sore, infected or damaged.
Don’t shake or shake vigorously the Accretropin vial (bottle). A vigorous shaking could destroy the medication. Use a gentle swirling movement. Don’t use the medicine in case it has changed colour or appears cloudy. Contact your physician for a new prescription.
Make sure to use each disposable needle once. Recycle used needles using containers that are puncture-proof (ask your pharmacist for one and the best way to get rid of it). Make sure this container is out of reach of pets and children.
To make sure that the medication is working for you and is not causing harm, your growth and blood levels will require testing frequently. Your eyes might also need to be examined. It is essential to not skip any scheduled appointments with the doctor.
Accretropin must be stored at room temperature in the refrigerator. Avoid shaking or freezing. Avoid using after the expiration date indicated on the label of the carton and vial.
Once it is opened, Accretropin may be stored for up to 14 days refrigerated. Discard 14 days after first use. Be sure to keep away from light.
How do I deal with it if do not take the dose?
Take the medication as soon as you can remember. If it’s almost time to take the next dose you missed, do not miss the dose and apply for the medicine when you are scheduled for the next time. Don’t take extra medication to replace the missed dose.
Contact your doctor if have missed more than three doses in the same row.
How do I react if take too much?
Get medical attention immediately If you suspect you’ve taken excessive amounts of this medication.
The symptoms of an overdose can be characterized by shaking or tremors as well as cold sweats, an increase in appetite, headache weakening, drowsiness quick heartbeat, dizziness and nausea. The signs of an overdose that last for a long time could include the growth of excessively.
Accretropin side effects
If you suffer from Prader-Willi syndrome contact your physician immediately when you notice signs of breathing issues, such as coughing, shortness of breath and/or new or increased snoring. Very rare cases of breathing difficulties have been seen in patients suffering from Prader-Willi syndrome who are taking Accretropin.
Contact your doctor immediately If you experience any of the symptoms that indicate an allergic reaction, such as asthmatic hives, difficulty breathing and swelling of your lips, face or tongue. Contact your doctor immediately in case you experience any of the following serious adverse effects:
- extreme and sudden discomfort or tenderness in your stomach area;
- nausea vomiting, sweating fast heartbeat, yellowing of eyes or skin, chest pain
- an increase in thirst and urination;
- extreme and sudden discomfort behind your eyes and vision changes
- swelling in your face, head hands or feet swelling in your hands, face, or feet
- Tingling or numbness in your hand, wrist fingers, or wrists.
The less serious side effects could be:
- headache;
- Soreness, redness, itching, pain or bleeding where the medication was injected
- Breast swelling;
- Joint pain and swelling or stiffness;
- mild nausea, stomach pain, gas.
This isn’t a complete list of possible side effects, and other side effects could be present. Discuss with your physician any unusual or unpleasant adverse reaction.
What other drugs can have an effect on Accretropin?
Before you start using Accretropin inform your physician whether you take insulin or take any oral (by mouth) medication in order to manage diabetes. Accretropin can alter blood sugar levels and may require you to alter the dosage of the medication for diabetes.
The most commonly prescribed diabetes medications are Acetohexamide (Dymelor) as well as chlorpropamide (Diabinese) as well as Glimepiride (Amaryl) and Glipizide (Glucotrol) and glyburide (Diabeta, Micronase), tolazamide (Tolinase) as well as tolbutamide (Orinase). Do not alter the dosage of your diabetes medication without consulting your physician’s guidance.
Consult your physician if taking any type of steroid medication, such as cortisone (Cortef, Cortone), the hormone methylprednisolone (Medrol) or prednisone (Deltasone, Orasone), prednisolone (Prelone, Pediapred), and dexamethasone (Decadron). Steroids could create Accretropin less effective, and dosages could require adjustment. Don’t stop using any steroid at once. Follow the prescriptions of your doctor.
This isn’t a complete list, and there could be other medications that interfere with Accretropin. Discuss with your doctor all prescription and over-the-counter drugs you are taking. This includes minerals, vitamins as well as herbal products and medicines prescribed by other doctors.