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Brand Name :
Wayrilz
Synonyms :
Rilzabrutinib
Class :
Bruton Tyrosine Kinase Inhibitors
Brand Name :
Wayrilz
Synonyms :
Rilzabrutinib
Class :
Bruton Tyrosine Kinase Inhibitors
Adult
Dosage Forms & Strengths
Tablet
400 mg
Take dose of 400 mg orally two times in a day
Dosage Modifications
Renal impairment
For mild to moderate: Dosage adjustments not required
For severe: Avoid use
Hepatic impairment
For mild: Dosage adjustments not required
For moderate or severe: Avoid use
Dosing Considerations
Perform test for pregnancy in women who are capable of bearing children.
Safety and efficacy not recommended
Refer to the adult dosing
An autoimmune condition known as immune thrombocytopenia (ITP) is caused by severe bleeding, bruising, and a low platelet count.
It is caused by a complicated immune system dysregulation that impairs platelet synthesis and increases the level of platelet destruction.
The synthesis of autoantibodies usually with IgG type that attached to platelet glycoproteins.
This binding designates the platelets for removal through splenic and hepatic macrophage phagocytosis.
Frequency defined
>10%
Diarrhea
Abdominal Pain
COVID-19 infection
Nausea
Headache
Neutropenia
1-10%
Vomiting
Dyspepsia
Arthralgia
Nasopharyngitis
Cough
<1%
Urinary tract infection
Wound infection
COVID-19 infection
Kidney abscess
Frequency Not Defined
Arthralgia
Dyspepsia
Pain in extremity
Pneumonia
Abdominal discomfort
Erythema nodosum
None
Contraindications
None
Cautions
Hepatotoxicity
Infection
Embryo-fetal toxicity
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
An intracellular signalling protein that is expressed by B cells, mast cells, and macrophages among other immune cells.
BTK signalling is involved in ITP by helping B cells produce anti-platelet autoantibodies and macrophages destroy platelets through FcÎłR.
Rilzabrutinib modulates the immune system to provide its therapeutic impact in ITP. It prevents the spleen and liver’s FcÎł receptor (FcÎłR) from phagocytosing antibody-coated cells and inhibits B cell activation.
Pharmacodynamics:
The effects of rilzabrutinib on B cell activation resulted in decreased autoantibody production and decreased autoantibody signalling mediated by the FcÎłR pathway in vitro.
Due to its gradual dissociation from BTK, rilzabrutinib has a long duration of action on the target and a brief systemic exposure period.
BTK occupancy in peripheral blood mononuclear cells was sustained over a 24-hour period at therapeutic dosages in healthy subjects.
Pharmacokinetics:
Absorption:
It shows oral bioavailability up to 4.7%.
It takes two hours to reach the median time to peak plasma concentration (Tmax).
Distribution:
It has volume of distribution of 149 L.
It shows protein binding up to 97.5%.
Metabolism:
It metabolized through CYP3A pathways.
Excretion and elimination:
The half-life ranging between 1.6 to 4.5 hours.
Around 86% of the dose was recovered in feces.
It is available in tablet form for oral use.
Patient should take dose with or without food at about same time each day
Take with meals if patient faces stomach issues.
Do not cut, crush, or chew the pills as well as swallow whole tablet with a glass of water.
Avoid using H2-receptor antagonists or antacids for at least two hours.
Avoid using starfruit, grapefruit, and Seville oranges at the same time.
As soon as possible take the missing dosage that same day, at least two hours before your next regularly scheduled dose.
Generic Name: rilzabrutinib
Why do we use rilzabrutinib?
Rilzabrutinib is used in the treatment of adult patients with immune thrombocytopenia.
It is indicated for people with persistent or chronic ITP whose response to a prior therapy was inadequate.
Rilzabrutinib is a reversible, covalent inhibitor of Bruton’s tyrosine kinase (BTK) used to treat immune-mediated and autoimmune disorders.
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