Overview:
Somapacitan is a drug used to substitute growth hormone and is administered in patients with growth hormone deficiency. The drug was first approved by the Food and Drug Administration in 2020. It is the first growth hormone therapy administered in adults once a week. All other growth hormone injections are usually injected every day. The drug is administered subcutaneously, under the skin, and has many uses. The drug has been evaluated in over 300 patients over randomized control trials and double-blinding methods.
How Does Sompacitan Work?
Somtopacitan is a growth hormone therapy taken once a week by injection under the skin. The active ingredient of Somapacitan is Sogorya, which is similar to the human growth hormone. When injected, the drug binds to the blood via a protein called albumin responsible for carrying oxygen.
Uses:
The drug is used as a replacement for growth hormone deficiency. It acts on the receptors and stimulates the production of the hormone, which is essential for various activities. It helps promote an individual's growth and maintains organs and tissues throughout the lifetime. Reduced growth hormone could affect the growth of the individual in all aspects.
Dosage:
The drug dosage may vary with each individual, depending on the treatment requirements and body weight. It is important to follow the instructions suggested by the doctor to avoid overdosing. The amount of medicine taken in a day and the number of times the medicine is injected depends on the objective of the treatment. Initially, a dose of 1.5 milligrams once a week is prescribed for adults with a growth hormone deficiency. However, the dose is at most 8 milligrams in a week. For children, the exact dose is determined only by the doctor.
Warnings:
Allergies - Inform the doctor beforehand regarding any unusual reactions to the drug or any other medication used. Also, inform any other forms of allergies like foods, preservatives, or dyes.
Pediatric - Appropriate studies are yet to prove the usage of the drug in children. Hence, the safety of the drug and its efficacy is not known.
Geriatric - The studies conducted do not specify any geriatric problems. However, older individuals are more sensitive to the drug and may demand dosage alterations for better efficacy.
Breast Feeding - There are not many studies regarding the side effects of the drug in breastfeeding mothers. It is better to weigh the potential risks before drug administration to avoid complications in children.
For Patients
What Is Growth Hormone Deficiency?
It is a disorder in which an individual experiences inadequate growth due to the anterior pituitary gland's decreased production of growth hormone. It is a small gland located at the base of the brain and produces several hormones.
Learn More About Sompacitan:
When and How Often to Take Somapacitan?
Somapacitan can be availed only via prescription and is unavailable over the counter. It is given as a subcutaneous shot under the skin of the stomach or thighs. It could also be administered at home under the guidance of a doctor. It is usually injected once a week.
How Effective Is Sompacitan?
The drug is very effective in treating growth hormone deficiency by just administering a single dose every week. It has proven to be effective compared to its counterparts.
Things to Inform The Doctor Before They Prescribe Somapacitan:
Before taking the drug, inform the doctor if there are any medical conditions or previous allergic reactions to any drug or foreign particles. Always carry current medication prescriptions to help the doctor prescribe medications accordingly.
Starting Sompacitan:
How to Take Somapacitan?
The drug is only available in the form of pre-filled injections. It has to be injected under the skin, preferably in the thigh or stomach area, as there are dense tissues to inject. It is to be administered every week as per the doctor’s prescription. The drug is effective for three to six days.
Things to Do After Starting Taking Somapacitan:
Look Out for Side Effects:
Some of the side effects that may occur with injecting Somapacitan are listed below. In case of any such side effects, consult the doctor immediately.
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Blurred vision.
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Chills.
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Cough.
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Darkened urine.
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Darkening of the skin.
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Depressed mood.
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Difficulty swallowing.
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Dizziness.
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Dry mouth.
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Dry skin and hair.
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Fainting.
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Fast heartbeat.
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Fever.
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Fruit-like breath odor.
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Hair loss.
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Hoarseness or husky voice.
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Increased hunger.
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Increased thirst.
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Increased urination.
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Indigestion.
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Loss of appetite.
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Loss of consciousness.
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Loss of fat or tissue weakness in the skin area at the injection site.
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Mental depression.
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Muscle cramps and stiffness.
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Nervousness.
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Pain in the stomach, side, or abdomen, possibly radiating to the back.
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Pale skin.
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Persistent non-healing sore.
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Pounding in the ears.
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Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue.
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A reddish patch or irritated area.
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A slow or fast heartbeat.
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Stomach pain.
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Sweating.
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Swelling.
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Tightness in the chest.
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Unexplained weight loss.
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Unusual bleeding or bruising.
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Unusual tiredness or weakness.
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Vomiting.
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Weight gain.
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Yellow eyes or skin.
Dietary Alterations:
Unless the doctor recommends, a balanced diet is sufficient when injecting the drug. Hence, no dietary alterations are required.
What Should Be Done When a Dose Is Missed?
In case of missing a dose, taking it as soon as possible is better. It is better to set a weekly reminder to avoid missing the dose as it may directly affect the treatment progress and may result in late recovery. Only double the dose after consulting the doctor. Always following a regular schedule with medications has proved or have better effects.
What Should Be Done to Treat Sompacitan Overdose?
Overdosing on Somapacitan is pretty rare. In case of overdoing it is important to call for medical assistance.
Some symptoms the patient may exhibit on overdosing on the drug are mentioned below.
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Swelling of hands.
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Excessive sweating.
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Enlarged hands.
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Muscle weakness.
How to Store Somapacitan?
Sompacitan is to be stored at room temperature, or it can be refrigerated. Do not freeze the drug. Ensure to keep the drug away from children and pets. Avoid using outdated or expired drugs by checking the label constantly. Since the drug comes in a prefilled pen, storing the remaining drug after the shot in the fridge is better. But, the drug should be used within six weeks after the first use. Ensure to keep the drug pen cap closed to prevent contamination.
How to Handle Sompacitan?
The drug is available as a prefilled pen with a patient information leaflet. Thoroughly go through the leaflet to understand the usage. The drug is injected subcutaneously into the stomach or thigh region. Ensure to use different body areas each time while administering the drug. This may prevent skin problems caused due to the injection. Also, it is important to use a new needle every time. Before injecting, it is important to check the color of the fluid. Generally, the fluid is clear; avoid using it if it is pale yellow or cloudy.
How to Dispose of Somapacitan?
After administering the drug, keep the needle separately in a container and dispose of it. Do not directly dispose of the drug in the dustbin; it is sharp and may harm anyone. The cartridge is also disposed of separately. Contact the community take-back program or biohazard waste management.
Avoid Self-Medication:
Self-medication without the consultation of a doctor is not advisable with any drugs. It could harm the body and may cause serious side effects. Injecting the drug per the doctor’s suggestion may help achieve the best results and treat the condition effectively.
Tips to Stay On Track:
In order to avoid skipping the dose, taking the injection on a fixed day every week is important. This may help to stay on track and understand the improvements occurring with regular use.
For Doctors
Indication:
The drug is indicated in adults with a growth hormone deficiency, especially when there is any malfunctioning of the anterior pituitary responsible for producing natural growth hormone. The drug replaces the natural hormone and acts on the hormonal sites, promoting growth. Growth hormone plays a vital role in the development of organs and tissues of an individual.
Pharmacology:
Mechanism of Action:
The drug binds to the growth hormone receptor and initiates intracellular signaling. This regulates the insulin-like growth factor. IGF-1 is responsible for bone and muscle growth.
Pharmacodynamics:
The drug specifically stimulates growth hormone receptors and has a long duration of action as it is administered weekly. The drug has a moderate therapeutic window, as it causes acute hypoglycemia followed by hyperglycemia. The risk of increased mortality in patients with critical illness and glucose intolerance should be counseled before starting the treatment.
Ingredients:
Active Ingredient: The active ingredient of Somapacitan is called Somapacitan-beco.
Inactive Ingredients:
The inactive ingredients are mentioned below
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Histidine.
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Mannitol.
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Phenol.
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Water for injection.
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Hydrochloric acid.
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Sodium hydroxide.
Absorption - A single drug dose may reach a Cmax of 14.4 nanograms per deciliter and a Tmax of 11.1 hours. The half-life of the drugs is nearly two to three days.
Distribution - An approximate volume of distribution of the drug is roughly 14.6 liters.
Metabolism - Studies have shown that in humans, the metabolism via cleavage of albumin binding moiety and linker sidechain before non-specific mechanisms.
Elimination - The drug is eliminated via urine and feces. About 81 percent of the drug is eliminated in the urine, and 13 percent is via feces.
Toxicity - In patients with acute overdose, the toxicity may present with fluid retention. Chronic overdoses can resemble conditions like gigantism or acromegaly. Treating The patients symptomatically and minimizing the permanent side effects are crucial aspects of the treatment.
Administration of the Drug:
The drug is injected slowly into the subcutaneous tissue, preferably over the thigh or stomach. After injecting, the injection site is slightly rubbed off to help with drug dispersion. Before administering, it is important to check if the site is sterilized. Use cotton and spirit to wipe the injection site. Then carefully take the injection and slowly administer the drug. After administering, recap the injection pen for future use for up to six weeks.
Considerations for Administration:
Before prescribing the drug, go through the medical and drug history of the individual. Also, check for any previous history of allergic reactions. Advise routine blood tests to check for sugar levels and blood count. The dosage of the drug depends on the weight of the individual.
Contraindications:
There are no specific contraindications for the drug. More care is to be taken in renal-impaired patients and pregnant women. In children, there are a few studies that support the drug administration. However, it is primarily used in adults.
Drug Interactions:
Somapacitan, when used in combination with conjugated estrogens, may reduce the efficacy of its action. The active metabolites of the drug can be reduced with Cortisone acetate. Hence it should be avoided to be combined with the above drugs to prevent complications.
Other Specifications:-
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Somapacitan in Pregnant Women: The drug's exact use and efficacy are yet to be known. Much research has been conducted to know the drug's safety in pregnant women. Hence it is safer to ask the patient if they are pregnant or have plans to become pregnant before the drug administration.
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Somapacitan in Lactating Women: The drug is not known to be used in lactating women as it may have potential risks to the child and is yet to be proven.
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Somapacitan in Pediatric Patients: The drug has to be helpful in pediatric patients with growth hormone deficiency. Studies are conducted to prove the efficacy. However, the dosage alterations are to be known.
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Somapacitan in Geriatric Patients: The drug is effective in elderly patients. However, a thorough history of pre-existing medical conditions plays a role in understanding the significance of drug administration. Patients with severe illnesses can be checked properly before considering drug administration.
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Somapacitan in Renal Impairment Patients: The drug undergoes kidney filtration and is eliminated from the body. So patients with impaired kidneys could experience discomfort or worsening of the pre-existing condition.
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Somapacitan in Hepatic Impairment Patients: The drug has minimal complications in patients with hepatic impairment.
