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Brand Name :
calquence
Synonyms :
acalabrutinib
Class :
Anticoagulant, Bruton’s tyrosine kinase inhibitors
Brand Name :
calquence
Synonyms :
acalabrutinib
Class :
Anticoagulant, Bruton’s tyrosine kinase inhibitors
Dosage Forms & Strengths
Capsule
100mg
Film-coated tablet
100mg
100
mg
Orally
every 12 hrs
Chronic Lymphocytic Leukemia (Cll)
Indicated for monotherapy:
100mg orally every 12 hours
In combination with Obinutuzumab
Cycle 1-Days 1-28: 100mg orally every 12 hours
Cycle 2-Days 1-28: Acalabrutnib-100mg orally every 12 hours
Day 1: Obinutuzumab-100mg intravenous infusion
Day 2: Obinutuzumab-900mg intravenous infusion
Days 8 and 15: Obinutuzumab-1000mg intravenous infusion
Cycle 3-7:
Day 1-28: Acalabrutnib-100mg orally every 12 hours
Day 1: Obinutuzumab-1000mg intravenous infusion
Cycle 8 and later cycles:
Day 1-28: Acalabrutnib-100mg orally every 12 hours
Management of grade adverse ≥3 reactions
• Grade ≥3 nonhematologic toxicities: The drug should be interrupted if the patient experiences grade≥3 nonhematologic toxicities. Once the toxicity resolves to Grade ≤1, the dose should be resumed at 100 mg orally twice a day
• Grade 3 thrombocytopenia with bleeding: The drug should be interrupted if the patient experiences Grade 3 thrombocytopenia with bleeding. Once the toxicity resolves to Grade ≤1, the dose should be resumed at 100 mg orally twice a day
• Grade 4 thrombocytopenia: The drug should be interrupted if the patient experiences Grade 4 thrombocytopenia. Once the toxicity resolves to Grade ≤1, the dose should be resumed at 100 mg orally twice a day
• Grade 4 neutropenia lasting >7 days: If the patient experiences Grade 4 neutropenia lasting longer than seven days, the drug should be interrupted. Once the toxicity resolves to Grade ≤1, the dose should be resumed at 100 mg orally twice a day
• First to the second occurrence: If the same toxicity occurs for a second time, the drug should be interrupted. Once the toxicity resolves to Grade ≤1, the dose should be resumed at 100 mg orally twice a day
• Third occurrence: If the same toxicity occurs for a third time, the drug should be interrupted. Once the toxicity resolves to Grade ≤1, the dose should be reduced to 100 mg orally every day
• Fourth occurrence: If the same toxicity occurs for a fourth time, the drug should be discontinued
Safety and efficacy not established
Refer adult dosing
may reduce the level of serum concentration of acalabrutinib
may reduce the level of serum concentration of acalabrutinib
may reduce the level of serum concentration of acalabrutinib
may reduce the level of serum concentration of acalabrutinib
may reduce the level of serum concentration of acalabrutinib
may decrease the diagnostic effect
may decrease the therapeutic effect of immunosuppressants
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may increase the neutropenic effect of myelosuppressive agents
may diminish the serum concentration
may diminish the serum concentration
may decrease the therapeutic effect of immunosuppressants
may decrease the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the myelosuppressive effect of myelosuppressive agents
measles, mumps, rubella, and varicella vaccine, live (Rx)
may decrease the therapeutic effect of immunosuppressants
measles mumps and rubella vaccine, live
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
vaccinia immune globulin intravenous (Rx)
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration of CYP3A4 inducers
may enhance the metabolism of clobetasol propionate
acalabrutinib: they may diminish the serum concentration of magnesium salts
acalabrutinib: they may diminish the serum concentration of magnesium salts
acalabrutinib: they may diminish the serum concentration of magnesium salts
acalabrutinib: they may diminish the serum concentration of magnesium salts
acalabrutinib: they may diminish the serum concentration of magnesium salts
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may diminish the serum concentration of CYP3A4 Inducers
It may enhance serum concentration when combined with CYP3A4 Inhibitors (Moderate)
may enhance the serum concentration of CYP3A4 Inhibitor
may diminish the serum concentration of antacids
aluminum hydroxide/magnesium carbonate
may diminish the serum concentration of Antacids
may diminish the serum concentration of antacids
may increase the serum concentration when combined with each other
acalabrutinib decreases clonidine metabolism when used in combination
may increase the immunosuppressive effect of immunosuppressants
may decrease the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may increase the toxic effect of immunosuppressants
may increase the serum concentration of acalabrutinib
may increase the serum concentration of acalabrutinib
may increase the serum concentration of acalabrutinib
may increase the serum concentration of acalabrutinib
may increase the serum concentration of acalabrutinib
It may diminish the effect when combined with phenobarbital by affecting the intestinal/hepatic enzyme CYP3A4
It may enhance the effect when combined with lonafarnib by affecting CYP3A4 metabolism
It may enhance the effect when combined with grapefruit by CYP3A4 metabolism
the serum concentration of acalabrutinib may be reduced by Inhibitors of the Proton Pump (PPIs and PCABs)
the serum concentration of acalabrutinib may be reduced by Inhibitors of the Proton Pump (PPIs and PCABs)
The use of strong CYP3A4 inhibitors may lead to elevated levels of acalabrutinib
when both drugs are combined, there may be an increased metabolism of acalabrutinib
when both drugs are combined, there may be an increased effect of acalabrutinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism
when both drugs are combined, there may be a decreased effect of acalabrutinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism
CYP3A strong enhancers of the small intestine may reduce the the bioavailability of acalabrutinib
when both drugs are combined, there may be increase in the serum concentration of acalabrutin
when both drugs are combined, there may be increase in the serum concentration of acalabrutin
may enhance the serum concentration of CYP3A4 inhibitors
may increase the immunosuppressive effect of Immunosuppressants
May may increase the anti-coagulant action when combined.
may increase the toxic effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the antiplatelet effect of antiplatelet agents
may increase the antiplatelet effect of antiplatelet agents
may increase the antiplatelet effect of antiplatelet agents
may increase the antiplatelet effect of antiplatelet agents
may increase the antiplatelet effect of antiplatelet agents
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the antiplatelet effect of antiplatelet agents
may increase the antiplatelet effect of antiplatelet agents
may increase the antiplatelet effect of antiplatelet agents
May have an increased antiplatelet effect when combined with Antiplatelet agents
may have an increased anticoagulant effect when combined with anticoagulants
may have an increased anticoagulant effect when combined with anticoagulants
may have an increased anticoagulant effect when combined with anticoagulants
may have an increased anticoagulant effect when combined with anticoagulants
may have an increased anticoagulant effect when combined with anticoagulants
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may diminish the metabolism when combined with azelastine
when netupitant is combined with acalabrutinib it can lead to a reduced metabolism of acalabrutinib
acalabrutinib is combined with mibefradil, there is a possibility of an enhanced concentration serum of acalabrutinib
The combination of troleandomycin may lead to a reduced metabolism of acalabrutinib
Combining tegafur with acalabrutinib can reduce tegafur’s metabolism
When domeperidone and acalabrutinib is used together, this leads to reduction in the domeperidone’s metabolism
When acalabrutinib is used together with fluconazole, this leads to reduction in the acalabrutinib metabolism
When acalabrutinib is used together with allylestrenol, this leads to a reduction in the acalabrutinib metabolism
When acalabrutinib is used together with oleandomycin, this leads to enhanced concentration serum of acalabrutinib
When acalabrutinib is used together with ridaforolimus, this leads to enhanced concentration serum of acalabrutinib
When acalabrutinib is used together with patupilone, this leads to enhanced concentration serum of acalabrutinib
acalabrutinib: it may decrease the metabolism of barnidipine
when used with quinupristin, acalabrutinib's metabolism may be lowered
acalabrutinib: it may enhance the toxic effect of Anti-Inflammatory Agents
acalabrutinib: it may enhance the toxic effect of Anti-Inflammatory Agents
aspirin, chlorpheniramine, and phenylephrine
acalabrutinib: it may enhance the toxic effect of Anti-Inflammatory Agents
acalabrutinib: it may enhance the toxic effect of Anti-Inflammatory Agents
acalabrutinib: it may enhance the toxic effect of Anti-Inflammatory Agents
an increase in the serum concentration of acalabrutinib may occur when combined with rokitamycin
By synergism effects, the toxicity of the other drug increases.
when both drugs combine the risk of both drug increases the toxicity of other by synergism.
both drug toxicity increases by synergism action.
Increased risk of myelosuppressive effects.
increase myelosuppressive effects by increasing serum concentration of daunorubicin
the synergistic effect is shown between acalabrutinib and mercaptopurine, leading to an increased risk of myelosuppression risk of infection increases on administering both the drugs simultaneously adalimumab: synergistic effect; causing immunosuppression risk of infection increases on administering both the drugs simultaneously
the levels of lenvanitib are increased by acalabrutinib or vice-versa.
increase the risk of myelosuppressive effects by pharmacodynamic synergism
when both drugs are combined, there may be an increased risk or severity of adverse effects
the effect of acalabrutinib is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
when used in combination, both the drugs increase the toxic levels of one another through synergistic activity
increase the risk of myelosuppressive effects by pharmacodynamic synergism
either of the drugs, when used in combination, increases the toxicity due to synergistic activity
The interaction may enhance the myelosuppressive effects
when both drugs are combined, there may be a reduced blood level of acalabrutinib
increase myelosuppressive effects by increasing serum concentration of idarubicin
metronidazole enhances the effect of acalabrutinib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
may increase the anti-platelet effect
may increase the anti-coagulant action of anti-coagulants
may increase the antiplatelet effect of antiplatelet agents
may increase the anticoagulant effect of Anticoagulants
It may enhance toxicity when combined with albendazole by pharmacodynamic synergism
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
when coupled with asunaprevir, acalabrutinib's metabolism can be accelerated
when used in combination with acalabrutinib, the therapeutic efficacy of carbimazole can be decreased
the metabolism of acalabrutinib can decrease when combined with dihydroergocristine
the rate of metabolism of acalabrutinib may be reduced with dihydroergocornine
the metabolism of acalabrutinib can be raised when combined with sulfinpyrazone
the serum concentration of acalabrutinib may increase when combined with ivacaftor
the serum levels of acalabrutinib may be increased
the toxicity of either of the drugs is increased due to pharmacodynamic synergism
the serum levels of acalabrutinib may be increased
the serum levels of abemaciclib may be increased
there may be a rise in abemaciclib's serum levels when coupled with carbomycin
when used with dalfopristin, acalabrutinib's metabolism may be lowered
The serum concentration of acalabrutinib can be increased when it is combined with fostamatinib
the risk of bleeding may be increased
Action:
The action of acalabrutinib works through BTK that is involved in the activation signaling of B-cells hence the decreased rate of proliferation and survival of the B-cells.
Spectrum:
Acalabrutinib’s spectrum of action is mostly seen in hematologic malignancies such chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma. It works well in other B-cell lymphomas as well.
Frequency defined:
>10%
All grades
Decreased platelets
Decreased neutrophils
Fatigue
Bruising
Rash
Constipation
Decreased hemoglobin
Headache
Diarrhea
Myalgia
Nausea
Abdominal pain
Grade≥3
Decreased neutrophils
Decreased hemoglobin
Vomiting
Decreased platelets
1-10%
All grades
Neutropenia
Thrombocytopenia
Upper respiratory tract infection
Musculoskeletal pain
Bruising
Diarrhea
Rash
Arthralgia
Nausea
Urinary tract infection
Anemia
Headache
Increased AST
Fatigue
Increased ALT
Increased uric acid
Dizziness
Hemorrhage
Increased bilirubin
Grade ≥3
Increased uric acid
Anemia
Lymphocytosis
Neutropenia
Infection
thrombocytopenia
<1%
All grades
Epistaxis
Hemorrhage
Grade ≥3
Increased AST
Headache
Vomiting
Increased ALT
Diarrhea
Abdominal pain
1-10% (In combination with Obinutuzumab)
Grade ≥3
Diarrhea
Fatigue
Musculoskeletal pain
Arthralgia
Lower respiratory tract infections
Upper respiratory tract infections
Rash
Hemorrhage
Headache
<1%(Monotherapy)
Grade ≥3
Fatigue
Rash
Hemorrhage
Nausea
Myalgia
Post-marketing reports
Opportunistic infections
Black box warning
None
Contraindications/caution
Contraindications
None
Caution
Hemorrhage
Infection
Atrial Fibrillation
Pneumonia
Tumor Lysis Syndrome
Drug Interactions
Pregnancy/Lactation
Pregnancy consideration: It may cause foetal harm when administered
Pregnancy category: D
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Pharmacology
BTK, a signalling molecule involved in the B-cell antigen receptor (BCR) and cytokine receptor pathways, is specifically inhibited by it.
Pharmacodynamics
It has a covalent interaction with a cysteine residue in the BTK active site, this interaction compromising the BTK activity for long time.
BTK is involved as a signalling molecule in the B-cell antigen receptor (BCR) and cytokine receptor pathways. Inhibition of BTK leads to the inhibition of B-cell signal transduction, activation, proliferation, migration, chemotaxis, survival, differentiation and adhesion.
Pharmacokinetics
Absorption
The absolute bioavailability of the drug is 25% and peak plasma concentration is 563 ng/mL.
Distribution
The protein bound is 97.5 % for acalabrutinib and Vd for steady state is 101 L.
Metabolism
Predominantly metabolized by CYP3A enzymes and to a minor extent by glutathione conjugation and amide hydrolysis.
Excretion/Elimination
Half-life: 1-hour for acalabrutinib
Excretion: 84% feces and 12% urine
Administration
It is taken orally as a tablet or as a capsule. Food does not alter the bioavailability of acalabrutinib as the capsule and tablet are bioequivalent.
Patient information leaflet
Generic Name: acalabrutinib
Pronounced: [ a-KAL-a-BROO-ti-nib]
Why do we use acalabrutinib?
This drug is used to treat several types of cancer, including:
This is for treatment of Mantle cell lymphoma (MCL) in patients who have received at least one previous treatment.
It is indicated for adult patients with CLL, including those with or without del(17p) deletion.
The treatment is used in adult patients with WM who have previously undergone any sort of treatment or therapy.
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