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(Description)
(Description)
|howSupplied=(Description)
|howSupplied=
|storage=(Description)
*Guselkumab Injection is a clear and colorless to light yellow solution that may contain small translucent particles. Guselkumab is supplied as a single-dose 100 mg/mL prefilled syringe:
:*NDC: 57894-640-01
|storage=
*Guselkumab is sterile and preservative-free. Discard any unused portion.
*Store in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).
*Store in original carton until time of use.
*Protect from light until use.
*Do not freeze.
*Do not shake.
*Keep out of reach of children.
|packLabel=
|packLabel=
|fdaPatientInfo=(Patient Counseling Information)
[[image:guselkumablabel1.jpeg|none|thumb|400px|This image is provided by the National Library of Medicine.]]
|nlmPatientInfo=(Link to patient information page)
|fdaPatientInfo=
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
*Advise the patient and/or caregiver to read the FDA-approved patient labeling before starting guselkumab therapy, and each time the prescription is renewed, as there may be new information they need to know.
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
=====Infections=====
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
*Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection
=====Instruction on Injection Technique=====
*Instruct the patient or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique. Instruct patients who are self-administering to inject the full dose of guselkumab.
*Instruct patients or caregivers in the technique of proper needle and syringe disposal. Needles and syringes should be disposed of in a puncture-resistant container. Advise patients and caregivers not to reuse needles or syringes.
*Remind patients if they forget to take their dose of guselkumab to inject their dose as soon as they remember. They should then take their next dose at the appropriate scheduled time.
[[image:guselkumabmedguide.png|none|thumb|400px|This image is provided by the National Library of Medicine.]]
|nlmPatientInfo=
|lookAlike=
|brandNames=
|brandNames=
*Tremfya
|drugShortage=Drug Shortage
|drugShortage=Drug Shortage


}}
}}

Revision as of 13:54, 16 July 2018

Guselkumab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sonya Gelfand

Disclaimer

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Black Box Warning

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Guselkumab is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

CONTRAINDICATIONS

Warnings

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1

(Description)

Conidition 2

(Description)

Conidition 3

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Guselkumab in women who are pregnant.

Labor and Delivery

(Description)

Nursing Mothers

(Description)g

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

There is limited information regarding the compatibility of Guselkumab and IV administrations.

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Guselkumab
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

  • Guselkumab Injection is a clear and colorless to light yellow solution that may contain small translucent particles. Guselkumab is supplied as a single-dose 100 mg/mL prefilled syringe:
  • NDC: 57894-640-01

Storage

  • Guselkumab is sterile and preservative-free. Discard any unused portion.
  • Store in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).
  • Store in original carton until time of use.
  • Protect from light until use.
  • Do not freeze.
  • Do not shake.
  • Keep out of reach of children.

Images

Drug Images

{{#ask: Page Name::Guselkumab |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Guselkumab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • Advise the patient and/or caregiver to read the FDA-approved patient labeling before starting guselkumab therapy, and each time the prescription is renewed, as there may be new information they need to know.
Infections
  • Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection
Instruction on Injection Technique
  • Instruct the patient or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique. Instruct patients who are self-administering to inject the full dose of guselkumab.
  • Instruct patients or caregivers in the technique of proper needle and syringe disposal. Needles and syringes should be disposed of in a puncture-resistant container. Advise patients and caregivers not to reuse needles or syringes.
  • Remind patients if they forget to take their dose of guselkumab to inject their dose as soon as they remember. They should then take their next dose at the appropriate scheduled time.
This image is provided by the National Library of Medicine.

Precautions with Alcohol

Alcohol-Guselkumab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

  • Tremfya

Look-Alike Drug Names

There is limited information regarding Guselkumab Look-Alike Drug Names in the drug label.

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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