TREMFYA Solution for injection (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Tremfya 100 mg solution for injection in pre-filled syringe. Tremfya 100 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
Tremfya 100 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution. Tremfya 100 mg solution for injection in pre-filled pen: Each pre-filled ...
Pharmaceutical form
Solution for injection (injection). The solution is clear and colourless to light yellow.
Therapeutic indications
Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Posology and method of administration
Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. Posology The recommended dose of Tremfya is 100 mg by subcutaneous ...
Contraindications
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infections (e.g., active tuberculosis, see section 4.4).
Special warnings and precautions for use
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. Infections Tremfya may increase ...
Interaction with other medicinal products and other forms of interaction
Interactions with CYP450 substrates In a Phase 1 study in subjects with moderate to severe plaque psoriasis, changes in systemic exposures (C<sub>max</sub> and AUC<sub>inf</sub>) of midazolam, S-warfarin, ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective methods of contraception during treatment and for at least 12 weeks after treatment. Pregnancy There are no data from ...
Effects on ability to drive and use machines
Tremfya has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse drug reaction (ADR) was upper respiratory infection. Tabulated list of adverse reactions Table 1 provides a list of adverse reactions from psoriasis ...
Overdose
Single intravenous doses of guselkumab up to 987 mg (10 mg/kg) have been administered in healthy volunteers and single subcutaneous doses of guselkumab up to 300 mg have been administered in patients with ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC16 Mechanism of action Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin ...
Pharmacokinetic properties
Absorption Following a single 100 mg subcutaneous injection in healthy subjects, guselkumab reached a mean (± SD) maximum serum concentration (C<sub>max</sub>) of 8.09 ± 3.68 mcg/mL by approximately 5.5 ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, toxicity to reproduction and pre- and post-natal development. In repeat-dose ...
List of excipients
Histidine Histidine monohydrochloride monohydrate Polysorbate 80 Sucrose Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
Nature and contents of container
<u>Tremfya 100 mg solution for injection in pre-filled syringe:</u> 1 mL solution in a pre-filled glass syringe with a fixed needle and a needle shield, assembled in an automatic needle guard. Tremfya ...
Special precautions for disposal and other handling
After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes ...
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Marketing authorization number(s)
EU/1/17/1234/001 1 pre-filled syringe EU/1/17/1234/002 1 pre-filled pen EU/1/17/1234/003 2 pre-filled pens EU/1/17/1234/004 2 pre-filled syringes
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 November 2017
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