CALQUENCE Capsule (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
AstraZeneca Pharmaceuticals LP
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Indications and Usage
1.1 Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated ...
2. Dosage and Administration
2.1 Recommended Dosage CALQUENCE as Monotherapy For patients with MCL, CLL, or SLL, the recommended dose of CALQUENCE is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable ...
3. Dosage Forms and Strengths
100 mg capsules.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Serious and Opportunistic Infections Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with CALQUENCE. Serious or Grade ...
6. Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious and Opportunistic Infections <em>[see Warnings and Precautions (5.1)]</em> ...
6.1. Clinical Trials Experience
As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
7. Drug Interactions
Strong CYP3A Inhibitors <em>Clinical Impact</em> • Co-administration of CALQUENCE with a strong CYP3A inhibitor (itraconazole) increased acalabrutinib plasma concentrations <em>[see Clinical Pharmacology ...
8.1. Pregnancy
Risk Summary Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated ...
8.2. Lactation
Risk Summary No data are available regarding the presence of acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production. Acalabrutinib and its active ...
8.3. Females and Males of Reproductive Potential
Pregnancy Pregnancy testing is recommended for females of reproductive potential prior to initiating CALQUENCE therapy. Contraception Females CALQUENCE may cause embryo-fetal harm and dystocia when administered ...
8.4. Pediatric Use
The safety and efficacy of CALQUENCE in pediatric patients have not been established.
8.5. Geriatric Use
Of the 929 patients with CLL or MCL in clinical trials of CALQUENCE, 68% were 65 years of age or older, and 24% were 75 years of age or older. Among patients 65 years of age or older, 59% had Grade 3 or ...
8.6. Hepatic Impairment
Avoid administration of CALQUENCE in patients with severe hepatic impairment. The safety of CALQUENCE has not been evaluated in patients with moderate or severe hepatic impairment <em>[see Recommended ...
11. Description
CALQUENCE (acalabrutinib) is an inhibitor of Bruton tyrosine kinase (BTK). The molecular formula for acalabrutinib is C<sub>26</sub>H<sub>23</sub>N<sub>7</sub>O<sub>2</sub>, and the molecular weight is ...
12.1. Mechanism of Action
Acalabrutinib is a small-molecule inhibitor of BTK. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK ...
12.2. Pharmacodynamics
In patients with B-cell malignancies dosed with 100 mg approximately every 12 hours, median steady state BTK occupancy of ≥95% in peripheral blood was maintained over 12 hours, resulting in inactivation ...
12.3. Pharmacokinetics
Acalabrutinib exhibits dose-proportionality, and both acalabrutinib and its active metabolite, ACP-5862, exposures increase with dose across a dose range of 75 to 250 mg (0.75 to 2.5 times the approved ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with acalabrutinib. Acalabrutinib was not mutagenic in an <em>in vitro</em> bacterial reverse mutation (AMES) assay or clastogenic in an <em>in vitro</em> ...
14. Clinical Studies
14.1 Mantle Cell Lymphoma The efficacy of CALQUENCE was based upon Trial LY-004 titled An Open-label, Phase 2 Study of ACP-196 in Subjects with Mantle Cell Lymphoma (NCT02213926). Trial LY-004 enrolled ...
16.1. How Supplied
Pack Size Contents NDC Number 60-count bottle Bottle containing 60 capsules100 mg, hard gelatin capsules with yellow body and blue cap, marked in black ink with ACA 100 mg 0310-0512-60 Distributed ...
16.2. Storage and Handling
Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Serious and Opportunistic Infections Inform patients of the possibility of serious infection and to report signs or symptoms ...