Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

ALIQOPA (NDA-209936)

(COPANLISIB DIHYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/07/2023 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infections

Additions and/or revisions underlined:

Grade 1 or 2 cytomegalovirus (CMV) reactivation or infection has occurred in 0.97% of patients treated with ALIQOPA monotherapy. Monitor for CMV infection during treatment with ALIQOPA in patients with a history of CMV infection. For clinical CMV infection or viremia, withhold ALIQOPA until infection or viremia resolves. If ALIQOPA is resumed, administer at the previous dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly [see Dosage and Administration (2.4)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

…

Before receiving ALIQOPA, tell your healthcare provider about all of your medical conditions, including if you:

…

have a history of cytomegalovirus (CMV) infection
…

have liver problems
…
What are the possible side effects of ALIQOPA?
ALIQOPA can cause serious side effects, including:
…

High blood pressure (hypertension). High blood pressure is common following ALIQOPA infusion and can sometimes be serious. Tell your healthcare provider if you develop any symptoms of hypertension during treatment with ALIQOPA, including:
- Dizziness o headache
- passing out o feel like your heart is pounding
  …

02/23/2022 (SUPPL-10)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.6 Hepatic Impairment

Additions underlined

Reduce ALIQOPA dose to 45 mg for patients with moderate hepatic impairment (Child-Pugh B). Reduce ALIQOPA dose to 30 mg for patients with severe hepatic impairment (Child-Pugh C) [see Dosage and Administration (2.2)]. No dose adjustment is required for patients with mild hepatic impairment (total bilirubin less than or equal to1 × upper limit of normal [ULN] and aspartate aminotransferase [AST] > ULN, or total bilirubin >1 to 1.5 × ULN and any AST) [see Clinical Pharmacology (12.3)].

10/28/2019 (SUPPL-3)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Effect of Other Drugs on Copanlisib

(additions underlined)

Strong CYP3A Inducers

Avoid concomitant use of ALIQOPA with strong CYP3A inducers. Concomitant use of ALIQOPA with strong CYP3A inducers may decrease copanlisib AUC and Cmax.

Examples of strong CYP3A inducers include: carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wortb.

Strong CYP3A Inhibitors

Concomitant use of ALIQOPA with strong CYP3A inhibitors increases the copanlisib AUC. If concomitant use with strong CYP3A inhibitors cannot be avoided, reduce the ALIQOPA dose to 45 mg. An increase in the copanlisib AUC may increase the risk of adverse reactions.

Examples of strong CYP3A inhibitors include: boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juicec, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, tipranavir and ritonavir, troleandomycin, voriconazole.

These examples are a guide and not considered a comprehensive list of all possible drugs that may fit this category. The healthcare provider should consult appropriate references for comprehensive information.

The induction potency of St. John’s wort may vary widely based on preparation.

The effect of grapefruit juice varies widely among brands and is concentration-, dose-, and preparation-dependent. Studies have shown that it can be classified as a “strong CYP3A inhibitor” when a certain preparation was used (e.g., high dose, double strength) or as a “moderate CYP3A inhibitor” when another preparation was used (e.g., low dose, single strength).