Lumirix Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Summary of the safety profile: Safety was primarily evaluated in the pivotal studies, for up to one year. In the long-term extension study (see Pharmacology: Pharmacodynamics under Actions), safety up to 2 years was consistent with the profile reported in the pivotal studies. The most common adverse reaction is application site acne (5.8%).
Tabulated list of adverse reactions: Adverse reactions are ranked under headings of frequency, with the most frequent first, using 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). (See Table 2.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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ruxolitinib

Manufacturer:

Rxilient

Distributor:

KLN Pharma