Guselkumab

Contraindications

None

Cautions

May increase infection risk; consider risks and benefits in patients with a chronic infection or history of recurrent infection; discontinue drug if patient develops serious infection or is not responding to therapy

Do not initiate in patients with clinically important active infection until infection resolves or is adequately treated

Screen for tuberculosis (TB) before initiating treatment; initiate treatment for latent TB prior to administering guselkumab

Consider completion of all age-appropriate immunizations before initiating guselkumab; avoid live vaccines

Drug interaction overview

• Avoid use of live vaccines
• CYP450 substrates
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, interleukin [IL]-1, IL-6, IL-10, tumor necrosis factor-alpha, interferon) during chronic inflammation
  • Guselkumab may modulate serum levels of some cytokines
  • Therefore, upon initiating or discontinuing guselkumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate

Do not receive a "live" vaccine while using guselkumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Other drugs may interact with guselkumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

General

Guselkumab is available in the following dosage form(s) and strength(s):

Injection: 100 mg/mL in a single-dose prefilled syringe.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.1

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Signs of a common cold.
• Headache.
• Irritation where the shot is given.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Antipsoriatic Agent
• Interleukin-23 Inhibitor
• Monoclonal Antibody

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Store at 2°C to 8°C (36°F to 46°F) in the original carton; do not freeze. Protect from light. Do not shake.

Do not receive a "live" vaccine while using guselkumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Other drugs may interact with guselkumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Red, painful, or itchy skin that is hot to touch.
• Shortness of breath.
• Cough with or without phlegm or blood.
• Weight loss.
• Passing urine more often.
• Loose stools (diarrhea).
• Stomach pain.
• Sweating a lot.
• Muscle pain.

Data not available

>10%

Infections, general (23%); compared with 21% in placebo group

Upper respiratory tract infections (14.3%)

1-10%

Headache (4.6%)

Injection site reactions (4.5%)

Arthralgia (2.7%)

Diarrhea (1.6%)

Gastroenteritis (1.3%)

Tinea infections (1.1%)

Herpes simplex infections (1.1%)