Guselkumab interacts in the following cases:
Prior to initiating therapy with guselkumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. Live vaccines should not be used concurrently in patients treated with guselkumab. No data are available on the response to live or inactive vaccines.
Before live viral or live bacterial vaccination, treatment with guselkumab should be withheld for at least 12 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should consult the Summary of Product Characteristics of the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Serious hypersensitivity reactions have been reported in the post-marketing setting. Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea. If a serious hypersensitivity reaction occurs, administration of guselkumab should be discontinued immediately and appropriate therapy initiated.
There are no data from the use of guselkumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of guselkumab in pregnancy.
It is unknown whether guselkumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, and decrease to low concentrations soon afterwards; consequently, a risk to the breast-fed infant during this period cannot be excluded. A decision should be made whether to discontinue, or abstain from initiating treatment with guselkumab, taking into account the benefit of breast-feeding to the child and the benefit of guselkumab therapy to the woman.
Women of childbearing potential should use effective methods of contraception during treatment and for at least 12 weeks after treatment.
The effect of guselkumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Guselkumab has no or negligible influence on the ability to drive and use machines.
The most common adverse drug reaction (ADR) was upper respiratory infection.
The following list provides adverse reactions from psoriasis clinical studies as well as from post-marketing experience. The adverse reactions are classified by MedDRA System Organ Class and frequency, 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).
Very common: Upper respiratory infections
Common: Gastroenteritis
Common: Herpes simplex infections
Common: Tinea infections
Uncommon: Hypersensitivity
Common: Headache
Common: Diarrhoea
Common: Urticaria
Uncommon: Rash
Common: Arthralgia
Common: Injection site erythema
Uncommon: Injection site pain
In two phase III clinical studies through the placebo-controlled period, gastroenteritis occurred more frequently in the guselkumab-treated group (1.1%) than in the placebo group (0.7%). Through Week 156, 4.9% of all guselkumab-treated patients reported gastroenteritis. Adverse reactions of gastroenteritis were non-serious and did not lead to discontinuation of guselkumab through Week 156.
In two phase III clinical studies through Week 48, 0.7% of guselkumab injections and 0.3% of placebo injections were associated with injection site reactions. Through Week 156, 0.5% of guselkumab injections were associated with injection site reactions. Adverse reactions of injection site erythema and injection site pain were generally mild to moderate in severity; none were serious, and none led to discontinuation of guselkumab.
The immunogenicity of guselkumab was evaluated using a sensitive and drug-tolerant immunoassay. In pooled phase II and phase III analyses, fewer than 6% of patients treated with guselkumab developed antidrug antibodies in up to 52 weeks of treatment. Of the patients who developed antidrug antibodies, approximately 7% had antibodies that were classified as neutralizing, which equates to 0.4% of all patients treated with guselkumab. In pooled phase III analyses, approximately 9% of patients treated with guselkumab developed antidrug antibodies in up to 156 weeks of treatment. Antidrug antibodies were not associated with lower efficacy or development of injection-site reactions.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
