To view this email as a web page, go here.

To make sure you continue to receive this e-newsletter, please add info@iononline.com to your address book.

specialty-spotlight-hero
CALQUENCE
 
 
Learn about a treatment option for your patients
CALQUENCE® (acalabrutinib) 100 mg capsules
View Prescribing Information, Important Safety Information
 
 
CALQUENCE® (acalabrutinib) 100 mg capsules
* Independent Review Committee-assessed per 2014 Lugano Classification response criteria for non-Hodgkin lymphoma (NHL).1
 
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
 
CALQUENCE® (acalabrutinib) 100 mg capsules
 
NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) recommend acalabrutinib (CALQUENCE) as a second-line therapy option for MCL (Category 2A)†2
 
For more details about the guidelines update, speak to your AstraZeneca representative or visit NCCN.org.
 
 
  NCCN makes no warranties of any kind whatsoever regarding their content, use or applications and disclaims any responsibility for their application or use in any way.
 
Please see full Important Safety Information below.
  Learn more at calquence.com/physician  
 
 
SELECT IMPORTANT SAFETY INFORMATION
Hemorrhage
Serious hemorrhagic events, including fatal events, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher bleeding events, including gastrointestinal, intracranial, and epistaxis, have been reported in 2% of patients. Overall, bleeding events, including bruising and petechiae of any grade, occurred in approximately 50% of patients with hematological malignancies.
The mechanism for the bleeding events is not well understood.
CALQUENCE may further increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding CALQUENCE for 3 to 7 days pre- and post-surgery, depending upon the type of surgery and the risk of bleeding.
 
CALQUENCE® (acalabrutinib) 100 mg capsules
Focused on efficacy with durable responses in R/R MCL*‡
 
80% ORR [95% CI: 72, 87]; 40% CR [95% CI: 31, 49]1
Median DoR not reached at 15.2 months median follow-up (range 0.3-23.7 months)1,3
Proven safety profile
 
The most common (≥20%) adverse drug reactions were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising1
Warnings and precautions include hemorrhage, infections, cytopenias, second primary malignancies, and atrial fibrillation/flutter1
Twice-daily dosing1
 
One 100-mg capsule is taken orally approximately every 12 hours until disease progression or unacceptable toxicity
May be taken with or without food
Avoid co-administration with proton pump inhibitors. Stagger dosing with H2-receptor antagonists and antacids
The Phase 2 ACE-LY-004 study excluded patients treated with BTK or BCL-2 inhibitors, and concomitant warfarin or equivalent vitamin K antagonists.
LY-004 was a Phase 2, open-label trial of CALQUENCE monotherapy in adult patients with MCL who had received 1 prior therapy (N =124). The major efficacy outcome was overall response rate and the median follow-up was 15.2 months.1
CR=complete response; DoR=duration of response; ORR=overall response rate.
 
 
 
 
IMPORTANT SAFETY INFORMATION (Cont'd)
Infection
Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have occurred.
Monitor patients for signs and symptoms of infection and treat as medically appropriate. Consider prophylaxis in patients who are at increased risk for opportunistic infections.
Cytopenias
In the combined safety database of 612 patients with hematologic malignancies, patients treated with CALQUENCE monotherapy experienced Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (11%), and thrombocytopenia (8%), based on laboratory measurements. Monitor complete blood counts monthly during treatment.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612 patients. The most frequent second primary malignancy was skin cancer, reported in 7% of patients. Advise protection from sun exposure.
Atrial Fibrillation and Flutter
In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients. Monitor for atrial fibrillation and atrial flutter and manage as appropriate.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) of any grade were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%).
*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.
The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%).
Dosage reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively.
Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid co-administration with a strong CYP3A inhibitor. If a strong CYP3A inhibitor will be used short-term, interrupt CALQUENCE.
Moderate CYP3A Inhibitors: When CALQUENCE is co-administered with a moderate CYP3A inhibitor, reduce CALQUENCE dose to 100 mg once daily.
Strong CYP3A Inducers: Avoid co-administration with a strong CYP3A inducer. If a strong CYP3A inducer cannot be avoided, increase the CALQUENCE dose to 200 mg twice daily.
Gastric Acid Reducing Agents: If treatment with a gastric acid reducing agent is required, consider using an H2-receptor antagonist or an antacid. Take CALQUENCE 2 hours before taking an H2-receptor antagonist. Separate dosing with an antacid by at least 2 hours.
Avoid co-administration with proton pump inhibitors. Due to the long-lasting effect of proton pump inhibitors, separation of doses may not eliminate the interaction with CALQUENCE.
SPECIFIC POPULATIONS
There is insufficient clinical data on CALQUENCE use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.
It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for at least 2 weeks after the final dose.
INDICATION AND USAGE
CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor 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 approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please see full Prescribing Information.
You may report side effects related to AstraZeneca products by clicking here.
References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP, 2017. 2.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed May 17, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. 3. Data on File, REF-18540. AstraZeneca Pharmaceuticals LP.
 
CALQUENCE® (acalabrutinib) 100 mg capsules
 
Prescribing Information CALQUENCE.com/physician
 
 
 
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
©2018 AstraZeneca. All rights reserved. US-22327 Last Updated 7/18 AstraZeneca logo
 
 

This email was sent to: Amy.Gonsuron@iononline.com

This email was sent by: ION Solutions, An AmerisourceBergen Company
3101 Gaylord Parkway Frisco, TX 75034 USA


We respect your right to privacy - view our policy

This communication is intended to keep ION members current on late breaking events. It may contain confidential information such as pricing, rebate, and other discount arrangements being provided exclusively to ION members, and as such is intended solely for the use of the addressee. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, copying, distribution or other use of this material is strictly prohibited. In the event that you have received this material in error, or wish to opt-out of any future emails, please Go Here or notify the sender immediately via email or telephone at 866-565-1070 and destroy all copies. Thank you.