Description
Tesamorelin injection is a hormone similar to the one normally released from the hypothalamus gland in the brain. It is used to reduce excess fat (lipodystrophy) in the stomach area in patients with human immunodeficiency virus (HIV) infection.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tesamorelin injection in the pediatric population. Safety and efficacy have not been established. Use is not recommended in children with open epiphyses (bones are still growing) or closed epiphyses (bones stopped growing).
Geriatric
No information is available on the relationship of age to the effects of tesamorelin injection in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to mannitol, history of or
- Cancer, active or history of or
- Pituitary gland tumor or surgery—Should not be used in patients with these conditions.
- Breathing problems or lung disease (eg, acute respiratory failure) or
- Cancer, history of or
- Carpal tunnel syndrome or
- Diabetes or
- Edema (fluid retention or swelling) or
- Heart surgery or
- Retinopathy (damage to the retina) or
- Stomach surgery or
- Trauma—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under the skin of your stomach. z
Tesamorelin may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
Tesamorelin injection comes with a patient information leaflet and patient instructions. Read the instructions and make sure you understand:
- How to prepare the injection.
- Proper use of disposable syringes.
- How to give the injection.
- How long the injection is stable.
If you use tesamorelin at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas with scar tissue, hard bumps, or bruises, or into your belly button.
Use a new needle and syringe each time you inject your medicine.
You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial looks cloudy, discolored, or if you see particles in it, do not use it.
This medicine is available in 2 forms with different dosages: Egrifta SV® and Egrifta WR™. Use only the brand of medicine your doctor prescribed.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For HIV lipodystrophy:
- For injection dosage form (powder for solution) 1 milligram (mg) vial:
- Adults—2 mg injected under your skin once a day.
- Children—Use and dose must be determined by your doctor.
- For injection dosage form (powder for solution) 2 mg vial:
- Adults—1.4 mg (0.35 milliliters (mL) of the reconstituted solution) injected under your skin once a day.
- Children—Use and dose must be determined by your doctor.
- For injection dosage form (powder for solution) 11.6 mg vial:
- Adults—1.28 mg (0.16 milliliters (mL) of the reconstituted solution) injected under your skin once a day.
- Children—Use and dose must be determined by your doctor.
- For injection dosage form (powder for solution) 1 milligram (mg) vial:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Use the mixed solution right away. Throw away unused solution or mixture after mixing.
Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.
This medicine may cause swelling (fluid retention) in some parts of your body. Check with your doctor right away if you have an increase in joint pain, or numbness or tingling sensations in your hands or wrist.
Tesamorelin injection may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have difficulty in swallowing, fast heartbeat, skin itching, rash, or redness, swelling of the face, throat, or tongue, or trouble breathing after receiving this medicine.
This medicine may cause injection site reactions. Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Arm or leg pain
- difficulty with moving
- joint pain
- muscle pain or stiffness
Less common
- 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
Some side effects 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
- 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
Less common
- 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
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20074632
