Tesamorelin

Tesamorelin is made with growth hormone-releasing factor (GRF).

Tesamorelin is used to reduce excess fat around the stomach that is caused by taking certain HIV medications. This condition is also called lipodystrophy (LYE-poe-DIS-troe-fee).

Tesamorelin is not a weight-loss medication and should not be used to treat obesity.

Tesamorelin can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use tesamorelin if you are allergic to it, or if you have a history of tumor or surgery of your pituitary gland, a history of head injury or radiation treatment,

Before using tesamorelin, tell your doctor if you have heart disease, high blood pressure, kidney disease, diabetes, epilepsy, asthma, migraines, an adrenal gland disorder, or if you have ever had cancer, any type of tumor, or open heart surgery.

Also tell your doctor about any major illness or recent trauma or medical emergency.

You should not use tesamorelin if you are allergic to it, or if you have:

• cancer;
• a pituitary gland disorder;
• a history of pituitary gland tumor or surgery;
• a history of head injury or radiation treatment; or
• if you are pregnant.

To make sure you can safely take tesamorelin, tell your doctor if you have any of these other conditions:

• a history of cancer or any tumor (either benign or malignant);
• heart disease, high blood pressure;
• kidney disease;
• diabetes, eye problems caused by diabetes;
• epilepsy
• asthma;
• migraine headaches;
• adrenal gland disorder;
• if you have ever had open heart surgery; or
• if you have any major illness, or a recent trauma or medical emergency.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use tesamorelin if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Do not give this medicine to a child without medical advice.

Tesamorelin may be found in some form under the following brand names:

• Egrifta

Take tesamorelin exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) of your stomach area.

After mixing tesamorelin with sterile water for Injection, it should look clear and colorless, with no particles in it. Do not use tesamorelin if it looks cloudy, discolored, or if you see particles in it.

Do not use tesamorelin after the date on the Medication Box and tesamorelin vial. Do not use a syringe or needle more than one time.

Do not share your tesamorelin needles with another person. Sharing needles can result in the transmission of infectious diseases, such as HIV. Do not share your tesamorelin syringe with another person, even if the needle is changed.

You should inject tesamorelin into the skin on your stomach. Pick an injection site that is around your belly button to the left or right. Stay away from any area with scar tissue, bruises, reddening, infection, or irritation.

Change your injection site from one day to the next to prevent bruising or irritation.

Do not recap the needle or remove the needle from the syringe after you inject tesamorelin. Put your used tesamorelin needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in your household trash.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of tesamorelin at the same time.

Tesamorelin is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with injection instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Tesamorelin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

After mixing tesamorelin with a diluent, you must use it right away. Do not store the mixture for later use.

Tesamorelin is usually given once per day. Follow your doctor's dosing instructions very carefully.

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Never share a tesamorelin syringe with another person, even if you change the needle. Sharing syringes or needles can allow HIV or other diseases to pass from one person to another.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.

Store vials of tesamorelin powder in the refrigerator, do not freeze.

Store the diluent at room temperature away from moisture, heat, and light.

Throw away any unused vials after the expiration date on the label has passed.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A fast heartbeat.
• Very bad dizziness or passing out.
• Shortness of breath.
• Very bad joint pain.
• Pain or numbness in the hands or wrist.
• A burning, numbness, or tingling feeling that is not normal.
• A heartbeat that does not feel normal.
• Irritation where the shot is given.
• Redness or swelling where the shot is given.
• Pain where the shot was given.
• Itching where the shot is given.
• Bleeding where the shot is given.
• Mood changes.
• Low mood (depression).
• Swelling in the arms or legs.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Subcutaneous [preservative free]:

Egrifta: 1 mg (1 ea); 2 mg (1 ea [DSC])

SubQ: The abdomen is the preferred site of administration; rotate site within the abdomen. Avoid injection into scar tissue, bruises, or the navel.

The incidence of adverse reactions generally decreases with treatment continued beyond 26 weeks.

10%:

Immunologic: Antibody development (IgG: 48% to 50%)

Local: Injection site reaction (6% to 25%)

Neuromuscular & skeletal: Arthralgia (13%)

1% to 10%:

Cardiovascular: Peripheral edema (2% to 6%), hypertension (1% to 2%), chest pain (1%), flushing (1%), palpitations (1%)

Central nervous system: Paresthesia (2% to 5%), hypoesthesia (2% to 4%), carpal tunnel syndrome (2%), depression (2%), pain (2%), peripheral neuropathy (2%), insomnia (1%)

Dermatologic: Injection site pruritus (2% to 8%), skin rash (4%), urticaria at injection site (2%), pruritus (1% to 2%), night sweats (1%), rash at injection site (1%), urticaria (1%)

Endocrine & metabolic: Diabetes mellitus (5%), hyperglycemia

Gastrointestinal: Nausea (4%), vomiting (2% to 3%), dyspepsia (2%), abdominal pain (1%)

Hematologic & oncologic: Elevated glycosylated hemoglobin (5%), local hemorrhage (injection site: 2%)

Hypersensitivity: Hypersensitivity reaction (1% to 4%)

Immunologic: Antibody development (neutralizing; tesamorelin: 10%; hGHRH: 5%)

Local: Erythema at injection site (1% to 9%), pain at injection site (4%), irritation at injection site (3%), swelling at injection site (2%)

Neuromuscular & skeletal: Limb pain (3% to 6%), myalgia (1% to 6%), increased creatine phosphokinase (2%), muscle rigidity (2%), musculoskeletal pain (2%), joint stiffness (2%), joint swelling (1%), muscle spasm (1%), strain (1%)

<1% (Limited to important or life-threatening): Anemia, abscess (abdominal, appendix, perianal), basal cell carcinoma, benign prostatic hypertrophy, bipolar mood disorder, bone fracture (humerus, rib), bronchitis (viral), cardiac failure, cellulitis, cerebellar syndrome, coronary arteriosclerosis, dehydration, diarrhea, drug dependence, impaired glucose tolerance, intestinal obstruction (small), malignant neoplasm of rectum, mental status changes, mobility disorder, pneumonia, retinopathy (chorioretinopathy), sepsis, trigeminal neuralgia, upper respiratory tract infection

Serum IGF-1 levels should be monitored at baseline and during therapy due to the potential increased risk of malignancy from sustained elevation of IGF-1 levels. Serum glucose (prior to treatment initiation); monitor periodically for glucose metabolism changes. Monitor for retinopathy in patients with diabetes. Visceral adipose tissue (by waist circumference or CT scan). Monitor for fluid retention.

Commonly reported side effects of tesamorelin include: injection site reaction, erythema at injection site, bruising at injection site, irritation at injection site, and pain at injection site. Other side effects include: limb pain, myalgia, peripheral edema, and decreased glucose tolerance. See below for a comprehensive list of adverse effects.

Data not available