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Therapy should be initiated by a physician experienced in the management of HIV infection. Posology The recommended dose of ibalizumab is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks. 1. Missed dose If a maintenance dose (800 mg) of ibalizumab is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible.

Resume maintenance dosing (800 mg) every 2 weeks thereafter. Elderly The safety and efficacy of ibalizumab in geriatric patients (≥ 65 years of age) have not been established. Paediatric population The safety and efficacy of ibalizumab in children under the age of 18 years have not yet been established.

Medicinal Product no longer authorised 3 Method of administration Intravenous use Diluted ibalizumab solution should be administered by a healthcare professional. Ibalizumab should be administered as an intravenous infusion. Ibalizumab should not be administered as an intravenous push or bolus.

The duration of the first infusion (loading dose) should be no less than 30 minutes. If no infusion- associated adverse reactions have occurred, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes.

9%) solution for injection. All patients must be observed during and for 1 hour after completion of ibalizumab administration for at least the first infusion. If a reaction occurs, the infusion should be discontinued and appropriate medical therapies should be administered.

Prophylactic medication is not warranted prior to each infusion. If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter. 6.

0%). Tabulated list of adverse reactions A tabulated list of adverse reactions is presented in Table 1. Frequencies are defined as 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) and 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. 4) Uncommon Nervous system disorders dizziness, headache, paraesthesia Common tremor UncommonMedicinal Product no longer authorised 5 System organ class Adverse reaction frequency* Cardiac disorders ventricular extrasystoles, electrocardiogram abnormal Uncommon Vascular disorders hypertension, labile hypertension, orthostatic hypotension Uncommon Gastrointestinal disorders diarrhoea, nausea, vomiting Common dry mouth Uncommon Skin and subcutaneous tissue disorders rash**, dermatitis, dry skin Common papule, pruritus, erythema nodosum Uncommon General disorders and administration site conditions fatigue Common feeling hot Uncommon Injury, poisoning and procedural complications contusion Uncommon * Frequency was calculated based on 24 weeks of safety data from 153 subjects enrolled in Phase 2b study TMB-202 (n = 113) and Phase 3 study TMB-301 (n=40), as well as on at least 48 weeks of safety data from 27 subjects from TMB-301 that rolled-over into expanded access study TMB-311.

**Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, “rash pruritic” and “rash papular”. Description of selected adverse reactions Rash Rashes were common. e. within 1 to 3 weeks of the first dose of ibalizumab), were mild to moderate in intensity, and resolved within 1-3 weeks with continued ibalizumab administration.

g. cortisteroids and/or anti-histamine medicinal products). Out of the 153 subjects in Phase 2b and 3 clinical studies, one subject experienced a severe rash (non-serious). This subject had 8 adverse reactions of rash, including 1 event of macular rash, 1 event of generalized rash and 6 events of maculo-papular rash at different times during treatment with ibalizumab.

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. Immune reconstitution inflammatory syndrome (IRIS) In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (cART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.

Typically, such reactions have been observed within the first few weeks or months of initiation of cART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis jiroveci pneumonia.

Any inflammatory symptoms should be evaluated and treatment instituted when necessary. 8). Excipients with known effect Ibalizumab contains less than 1 mmol sodium (23 mg) in each loading dose of 2,000 mg or maintenance dose of 800 mg and therefore is essentially sodium-free.

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