TEPEZZA 500 mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What TEPEZZA is and what it is used for
2. What you need to know before you are given TEPEZZA
3. How TEPEZZA is given
4. Possible side effects
5. How to store TEPEZZA
6. Contents of the pack and other information

TEPEZZA is used to treat adults with moderate to severe Thyroid Eye Disease (TED).

Thyroid Eye Disease (TED) is anautoimmune condition where your immune system attacks the muscles and fat around the eyes. A protein called IGF-1R is found in the muscles and fat around the eyes. These muscles and fat help cushion the eyes and support their movement. In Thyroid Eye Disease, the immune system activates IGF-1R, causing inflammation and swelling in these tissues. This swelling pushes the eyes forward, causing them to bulge. It can also result in double vision, and in severe cases, may cause permanent vision damage.

• if you are allergic to teprotumumab or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

If you are not sure, talk to your doctor or nurse before being given TEPEZZA.

Talk to your doctor or nurse before you are given TEPEZZA.

• It is possible that TEPEZZA can cause an infusion reaction (reactions related to your injection of medicine). These reactions are usually mild but please let your doctor or nurse know if you have previously experienced problems after injections, such as breathlessness, increased heart rate, increased blood pressure, headache or muscle pain.
• It is possible that TEPEZZA may cause a worsening of your symptoms if you suffer from inflammatory bowel disease (IBD). Your doctor or nurse will monitor you for any signs of a flare of the disease and if necessary, discontinue treatment with TEPEZZA.
• TEPEZZA may cause hyperglycaemia or increased blood glucose, especially if you have pre-existing diabetes or impaired glucose tolerance. Your doctor or nurse will monitor glucose levels whilst you are being treated with TEPEZZA. If you have pre-existing diabetes your doctor will ensure that your diabetes is under control before starting TEPEZZA.
• It is possible that TEPEZZA may cause severe hearing loss or impairment. Before starting treatment, please tell your doctor if you have ever had any of the following:
  • Hearing problems or if you use hearing aids
  • Sensitivity to loud noises
  • A history of smoking

Your doctor will check your hearing before you start treatment and explain any potential side effects related to hearing and to stop smoking if you haven’t already.

Your doctor will continue to monitor your hearing during and after treatment with TEPEZZA. If you notice any changes in your hearing, please contact your doctor immediately.

TEPEZZA is not recommended in children and adolescents under 18 years of age because the safety and benefit have not been established in these patient populations.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

You must not use this medicine if you are pregnant. TEPEZZA may cause damage to your unborn baby. Your doctor should advise you about using contraception during treatment with TEPEZZA and for at least 6 months after the last dose of TEPEZZA.

Women of childbearing potential

The use of highly effective contraception during treatment and up to at least 6 months after treatment should be considered in women who are able to get pregnant.

While you are being treated with TEPEZZA you may experience fatigue or headaches. This may impair your ability to drive or use machines. Do not drive a car or operate machines if you have these symptoms.

If this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.

Your doctor will decide when you should be given your next dose of TEPEZZA. You should discuss this with your doctor.

Do not stop treatment with TEPEZZA unless you have discussed this with your doctor.

Infusion related reactions (may affect up to 1 in 10 people)

If you have an infusion related reaction, tell your doctor or nurse straight away. Your doctor will decide if you need to interrupt or stop treatment and when it's safe to start it again (see section 2 Warnings and precautions).

Deafness (may affect up to 1 in 10 people)

Tell your doctor immediately, if you experience deafness in one or both ears.

Exacerbation of inflammatory bowel disease (may affect up to 1 in 100 people)

TEPEZZA may cause worsening of inflammation of the digestive tract. Symptoms may include an increased number of loose stools with stomach pain or cramps, or blood in your stools.

Tell your doctor immediately. Your doctor will decide if you need to stop treatment.

Diabetic ketoacidosis (may affect up to 1 in 100 people)

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• increased levels of “ketone bodies” in your blood
• excessive thirst
• queasiness or vomiting
• feeling tired or confused
• stomach pain
• faster or deeper breathing
• fruity-smelling breath.

Contact your doctor immediately, if you develop any of these symptoms while being treated with TEPEZZA.

Most of the following side effects are mild to moderate. If any of these side effects become severe, tell your doctor or nurse.

Very common (may affect more than 1 in 10 people)

• High blood sugar (hyperglycaemia)
• Muscle spasms
• Feeling queasy, like you need to vomit (nausea)
• Hair loss (alopecia)
• Diarrhoea
• Headache
• Feeling extremely tired or lacking energy (fatigue)

Common (may affect up to 1 in 10 people)

• Change in the sense of taste (dysgeusia)
• Dry skin
• Feeling of blocked ears, or pressure in the ear (ear discomfort)
• COVID-19
• Problems with the tissue underneath the nail (nail bed disorder)
• Discolouring of the nails
• Nail splitting or breaking (onychoclasis)
• Loss of body weight.
• Partial loss of hearing (hypoacusis)
• Ringing in the ears (tinnitus)
• Hearing your own voice louder than normal (autophony, eustachian tube patulous), muffled hearing (eustachian tube dysfunction), hearing loss due to inner ear or nerve damage (neurosensory hypoacusis)
• Missing one or more periods (amenorrhea)
• Irregular periods
• Heavy periods
• Lighter periods (hypomenorrhea)
• Pain or cramping during your period (dysmenorrhea)

Uncommon (may affect up to 1 in 100 people)

• Ingrowing nail
• Damage to the ear drum (Tympanic membrane disorder)
• Sensitivity to particular sounds (Hyperacusis)

Not known (frequency cannot be estimated from the available data)

• Very high blood sugar levels for a long time – symptoms can include excessive thirst and altered levels of consciousness (hyperosmolar hyperglycaemic state).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

or search for MHRA Yellow Card in the Google Play or Apple App Store

• The active substance is teprotumumab.
• Each vial contains 500 mg powder for concentrate for solution for infusion
• The other ingredients are Histidine, histidine hydrochloride monohydrate, polysorbate 20 (E432) and trehalose dihydrate.

TEPEZZA is a powder for concentrate for solution, which is supplied in a glass vial with a rubber stopper containing 500 mg of teprotumumab. The powder is a white to off white powder for concentration for solution for infusion supplied in a single-dose vial. Each pack contains one vial.