Tepezza

Treatment with this medicinal product must be initiated and supervised by a physician experienced in the diagnosis and treatment of thyroid eye disease. It should be administered by a healthcare professional and under the supervision of a physician with access to appropriate medical support to manage infusion-related reactions.

Posology Dosing is based on the patient’s actual body weight. The recommended dose is 10 mg/kg of body weight for the initial dose followed by 20 mg/kg of body weight for 7 additional doses given once every three weeks as an intravenous infusion.

For the first 2 infusions, the diluted solution is administered as an intravenous infusion over at least 90 minutes. If well tolerated, infusions 3 to 8 can be administered over 60 minutes every three weeks (see Method of administration).

Clinical response is expected with 8 doses of treatment. Additional doses should not be administered if response is not achieved with this regimen. 4). 2). Renal impairment Renal impairment is generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies.

2). Hepatic impairment Hepatic impairment is generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies. 2). 3). The safety and efficacy of teprotumumab in adolescents whose growth is complete to less than 18 years has not been established.

No data are available. Method of administration • This medicinal product must be administered as an intravenous infusion. It must not be administered as an intravenous push or bolus. • Prior to infusion: - the powder must be reconstituted with water for injection.

9%) solution for infusion. • TEPEZZA must not be co-administered with other medicinal products through the same infusion line. • For the first 2 infusions, the diluted solution must be administered intravenously over at least 90 minutes.

If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes. • If the 60-minute infusion is not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes, the rate of infusion should be reduced and pre-medication is recommended for subsequent infusions.

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5%). 4). Tabulated list of adverse reactions Adverse reactions reported in clinical trials and derived from spontaneous reporting are listed below in table 1. The frequencies of adverse reactions are based on 4 placebo-controlled studies with 285 patients (teprotumumab = 152 patients; placebo = 133 patients).

Patients were exposed to teprotumumab for a median of 148 days. The adverse reaction frequencies from clinical trials are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than the medicinal product, such as the disease, other treatments or unrelated causes.

The adverse reactions are listed by MedDRA System Organ Class and by frequency. Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. 9% patients treated with teprotumumab and all were mild or moderate in intensity and transient and were successfully managed with antihistamines and/or corticosteroids, if needed.

4 for action to be taken in case of infusion-related reactions. 7%)]. 7%) with pre-existing hearing impairment reported an event of neurosensory hypoacusis, which led to the discontinuation of teprotumumab. 7%) with pre-existing hearing impairment reported a serious event of conductive deafness, also resulting in the discontinuation of teprotumumab.

4. 0%) were mild or moderate in severity and managed as needed with treatments used for glycaemic control. 7%) was reported in clinical studies for a patient who received a single-dose of teprotumumab. Post-marketing cases of hyperosmolar hyperglycaemic state have been reported.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions Teprotumumab may cause infusion reactions.

8). Infusion reactions may occur during any of the infusions or within 90 minutes after an infusion. Patients should be monitored closely throughout the infusion and for 90 minutes after completion of infusion. Following the monitoring period, patients should be advised to contact their healthcare professionals if symptoms of infusion-related reactions, including transient hypertension, feeling hot, tachycardia, dyspnoea, headache, abdominal pain, muscular pain, palpitations, rash, haptic hallucinations, sleep paralysis, nasal congestion, urticaria, or diarrhoea occur.

Based on the severity of the infusion-related reaction, infusion should be interrupted or discontinued, and appropriate medical management should be instituted. In patients who experience an infusion reaction, consideration should be given to pre-medicating with an antihistamine, antipyretic, corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Hearing impairment Teprotumumab may cause severe hearing impairment including hearing loss, which in some cases may be permanent. 8). Patients should be advised to report symptoms of altered hearing promptly to their healthcare professional.

For patients with pre-existing hearing impairment, worsening of hearing impairment symptoms during or after the completion of the treatment with teprotumumab can occur. The benefit-risk of treatment should be considered in these patients.

Patient’s hearing should be assessed using audiometry before starting treatment (first infusion), during treatment (around the third or fourth infusion) and after completing treatment with teprotumumab. If a patient experiences subjective hearing changes during treatment, additional audiometric assessments are recommended, as necessary.

1. 6). 4