Tesamorelin

Tesamorelin injection is a synthetic hormone similar to one normally released by the hypothalamus gland and is prescribed by doctors for treating excess fat in the abdomen known as lipodystrophy and apparent in patients with human immunodeficiency virus or HIV.

Overview

What is Tesamorelin?

Tesamorelin is also known by the brand name of Egrifta. It is a synthetic form of the hormone released by the hypothalamus gland called a growth hormone releasing hormone or GHRH. Use of Tesamorelin is by doctor’s prescription only and through an injection. It is used to treat an HIV associated disease known as lipodystrophy, which is a condition of excess fat in the abdominal area.

How does Tesamorelin work?

Tesamorelin works by stimulating the production and release of the hormone hGRF, which predisposes the patient to glucose intolerance which directly affects deep belly fat.

Why do HIV patients get lipodystrophy?

HIV patients experience an overall change in their body fat content and some of them have these changes manifested in their abdomens more than other places. The exact cause is not known; it could be due to the HIV infection and the effects it has on the body or it could be due to the medication prescribed for HIV.

The risk of lipodystrophy is higher in older HIV patients, in white people and in women. The length and severity of HIV infection is also a risk; the longer and more severe the infection, the more risk of lipodystrophy.

Why treat lipodystrophy?

Lipodystrophy can lead to serious health risks as an increase of body fat increases the risk of heart disease and diabetes. While there is no cure for lipodystrophy, drugs such as Tesamorelin can reduce the excess fat, causing health risks.

Conditions treated

  • Lipodystrophy

Type of medicine

  • Hormone

Side effects

Not all patients will experience side effects; some will not and some will have side effects that range from mild to severe. Check with your doctor immediately if you experience any of the following side effects:

  • Difficulty moving
  • Muscle pain or stiffness
  • Pain in the arms or legs
  • Pain in the joints
  • Blurred vision
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • Burning, numbness, pain, or tingling in all fingers except the smallest finger
  • Chest pain
  • Dizziness
  • Fast, irregular, pounding, or racing heartbeat or pulse
  • Headache
  • Nervousness
  • Pounding in the ears
  • Slow or fast heartbeat
  • Swelling of the joints
  • Unsteadiness or awkwardness
  • Weakness in the arms, hands, legs, or feet

Most side effects do not require medical attention and may go away after treatment with Tesamorelin is completed. Your health care professional may be able to give you instructions on how to lessen or prevent some of the side effects. If you have any of the following side effects for a long period of time or they become severe, contact your doctor:

  • 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 injection site
  • Muscle aching or cramping
  • Acid or sour stomach
  • Belching
  • Bone pain
  • Discouragement
  • Feeling of warmth
  • Feeling sad or empty
  • Heartburn
  • Indigestion
  • Irritability
  • Itching skin
  • Lack of appetite
  • Loss of interest or pleasure
  • Muscle spasms
  • Nausea
  • Night sweats
  • Rash
  • Redness of the face, neck, arms, and occasionally, upper chest
  • Sleeplessness
  • Stiffness of the joints
  • Stomach discomfort, upset, or pain
  • Strain in the muscles
  • Sudden sweating
  • Tiredness
  • Trouble concentrating
  • Trouble sleeping
  • Unable to sleep
  • Upper abdominal or stomach pain
  • Vomiting

Dosage

A trained health care professional such as a doctor or nurse will inject your first dose of Tesamorelin under your skin, typically in the stomach or abdomen. Tesamorelin should not be injected into the navel, into scar tissue or a bruised area.

Each patient will be prescribed a course of treatment with Tesamorelin according to their specific health status and other information. The following is an average dosage detail; what you are administered for a dose may vary.

Adults will be given, on average, two milligrams injected under the skin once per day. Treatment with Tesamorelin can exceed three to six months, so your doctor may show you how to give the injection yourself.

Read and understand all patient information provided with Tesamorelin including:

  • How to prepare the injection
  • Proper use and disposal of syringes
  • How to give the injection
  • How long the injection is stable

If you have any questions, be sure to ask your doctor. The areas of the abdomen where Tesamorelin is injected should be different each time, so keep track of where your shot was every time. This prevents skin problems and side effects in the injection area.

Missing a dose of Tesamorelin does not mean that you should double the next dose; if you are close to the time for your next dosage, skip the missed dose and get back to your regular schedule as soon as possible. Do not double up on doses of Tesamorelin for any reason.

Interactions

Inform your healthcare provider if you are allergic to Tesamorelin or any other drug prior to beginning treatment. If you are allergic to any dyes, preservatives, foods or animals, it is also best to inform your doctor before beginning Tesamorelin treatment.

It is of critical importance that you disclose your full medical history as well as details of any drugs you are currently taking or have taken in the recent past before you begin a course of treatment with Tesamorelin or any other drug. Be certain to include all prescription as well as non-prescription medications you may be taking and details of any vitamin, herbal or holistic supplements or treatments you are currently taking or have taken in the recent past.

No information is available on Tesamorelin injection with regard to the pediatric or geriatric population. Studies on pregnant women have shown that Tesamorelin injection has caused fetal abnormalities. Tesamorelin should not be used on pregnant women or women who may become pregnant. Breastfeeding women should discuss the risks of treatment with Tesamorelin with their health care provider.

Discuss with your doctor when to take Tesamorelin injection and if it is affected by food, alcohol or the use of other medications.

Other medications known to interact with Tesamorelin include:

  • Simavastatin
  • Ritonavir

Discuss the use of alcohol, illegal drugs or tobacco with your health care provider and how these substances are affected by a treatment regimen that includes Tesamorelin.

Other medical problems can also affect the effectiveness or compromise the safety of treatment with Tesamorelin. Your doctor may choose another course of treatment or change your dosage of Tesamorelin if you have one of the following conditions:

  • Allergy to mannitol
  • Cancer
  • Pituitary gland tumor or surgery
  • Pressure in the head
  • Breathing problems, lung disease, acute respiratory failure
  • Carpal tunnel syndrome
  • Diabetes
  • Edema (fluid retention or swelling)
  • Retinopathy (damage to the retina)
  • Surgery (e.g., heart, stomach)
  • Trauma
  • Kidney disease
  • Liver disease

In fact, it is not known whether Tesamorelin will be effective on patients who have liver disease. Consult with your doctor if you have been diagnosed with liver disease and are considering treatment with Tesamorelin.

Warnings

Your physician will want to monitor your progress while being treated with Tesamorelin and will most likely include blood and urine tests on a regular basis where office visits will be required.

Tesamorelin has been shown to harm unborn children and therefore is not recommended to treat women who are pregnant or those that may become pregnant. It is advised that women of childbearing age use an effective form of birth control to keep from getting pregnant while being treated with Tesamorelin. If you suspect you may be pregnant, contact your doctor immediately.

Patients may experience fluid retention and swelling in some parts of the body; if you experience this side effect while on treatment with Tesamorelin, contact your doctor immediately.

Tesamorelin may change blood sugar levels in some patients. If your blood or urine sugar test results are different than usual, check with your doctor.

Discontinue use of Tesamorelin and contact your healthcare professional if you notice a skin rash, hives or welts, have itchy or red skin, shortness of breath or swelling in the face, lips, hands or feet.

The use of other medicines, whether they are prescription, non-prescription, vitamin or holistic in nature is not recommended at the same time you are taking a course of Tesamorelin unless you have discussed them with your doctor.

Storage

Store Tesamorelin and the disposable syringes out of sight and reach of children. Pay attention to the expiration date and do not use or keep past this date. Consult with your doctor or pharmacist on how to safely dispose of unused or expired Tesamorelin and used needles and syringes. It is generally recommended that you dispose of used needles and syringes in a hard, closed container to avoid the needles poking through.

Use the mixed solution immediately and discard any unused solution following proper safety procedures. Store Tesamorelin in its original packaging in the refrigerator and protect it from light; do not allow the medication to freeze.

You will be required to keep a bottle of sterilized water for injection and this should be kept at room temperature along with syringes and needles. Again, keep these items out of sight and reach of children.

Summary

Tesamorelin injection is a synthetic hormone that is prescribed to patients who have been diagnosed with HIV and have experienced the onset of lipodystrophy. Lipodystrophy is the condition by which the body stores excess fat in the deep tissue of the abdomen. If left untreated, this excess fat can lead to increased risk of heart disease and diabetes.

Once per day, the patient is administered, either by a trained medical professional or by themselves, a shot of their dose of Tesamorelin. This treatment can take up to three to six months to show signs of improvement; some patients continue treatment longer to notice results.

Patients may experience side effects directly at the site of injection, which can be avoided if the site is varied every time. Patients may also experience side effects such as muscle aches or cramping, nausea, rash or sweating, which should be mild and not require medical attention. If side effects become severe, it is advised that the patient contact their doctor immediately.

Tesamorelin is not recommended for use in women who are pregnant or who may become pregnant. The effects on infants by the use of Tesamorelin on breast milk are not known, so these patients should consult their doctor before beginning treatment. Appropriate studies have not been done on age-related effectiveness of Tesamorelin injection, so use of this treatment as at doctor’s recommendation.

Avoid using other medications with this drug; consult with your doctor on any medications, whether they are prescription or not, you may be taking. Patients diagnosed with certain conditions, either currently or in the past, may experience a lowered effectiveness or worsening of these conditions when they are being treated with Tesamorelin. Your full medical history including family history and medications should be disclosed to your doctor before beginning treatment.

Your doctor or health care professional may give you the initial injection of Tesamorelin, training you fully on how to give the injection to yourself in future. While you’ll still be required to maintain a regular office visit schedule including blood and urine tests, you will store and administer the drug yourself on a daily basis. Tesamorelin vials should be stored in their original packaging in the refrigerator and away from heat, light and moisture. Do not allow Tesamorelin medication to freeze. The sterile water and syringes should be stored at room temperature. Practice safe disposal of all used syringes as well as unused and expired medication.

https://www.projectinform.org/publications/tesamorelin/

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Last Reviewed:
December 23, 2017
Last Updated:
December 22, 2017