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.

APTIVUS (NDA-021814)

(TIPRANAVIR)

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

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04/03/2024 (SUPPL-30)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Importance of Co-administration with Ritonavir

Newly added subsection:

APTIVUS must be co-administered with ritonavir and food to achieve the desired antiviral effect. Failure to administer APTIVUS with ritonavir and food may result in a loss of efficacy of tipranavir. Please refer to the ritonavir prescribing information for additional information on precautionary measures.

5.5 Effects on Platelet Aggregation and Coagulation

Additions and/or revisions underlined:

…

In rats, tipranavir treatment alone induced dose-dependent changes in coagulation parameters, bleeding events and death. Co-administration with vitamin E significantly increased these effects [see Nonclinical Toxicology (13.2)]. However, analyses of stored plasma from adult and pediatric subjects treated with APTIVUS capsules plus low-dose ritonavir showed no effect of APTIVUS/ritonavir on vitamin K-dependent coagulation factors (Factor II and Factor VII), Factor V, or on prothrombin or activated partial thromboplastin times.

…

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

There is no information regarding the presence of tipranavir in human milk, the effects on the breastfed infant, or the effects on milk production. Tipranavir is present in rat milk (see Data). Potential risks of breastfeeding include: (1) HIV-1 transmission (in HIV-1 negative infants), (2) developing viral resistance (in HIV-1-positive patients), and (3) adverse reactions in a breastfed infant similar to those seen in adults.

…

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of APTIVUS, co-administered with ritonavir have been established in pediatric patients for combination antiretroviral treatment of HIV-1 infected pediatric patients weighing 36 kg or higher who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor (PI) [see Indications and Usage (1) and Dosage and Administration (2.2)].

The safety, pharmacokinetic profile, and virologic and immunologic responses of APTIVUS

in those weighing 36 kg or higher were similar to those observed in adults. However, rash was reported more frequently in pediatric subjects than in adults [see Warnings and Precautions (5.6), Adverse Reactions (6.2), Clinical Pharmacology (12.3), and Clinical Studies (14.2)].

The safety and effectiveness of APTIVUS, co-administered with ritonavir have been established in pediatric patients greater than 2 years of age or weighing less than 36 kg, but not recommended due to lack of a suitable pediatric formulation.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Lactation
Inform individuals with HIV-1 infection that the potential risks of breastfeeding include: (1) HIV 1 transmission (in HIV-1–negative infants), (2) developing viral resistance (in HIV-1–positive infants), and (3) adverse reactions in a breastfed infant similar to those seen in adults [see Use in Specific Populations (8.2)].
PATIENT INFORMATION
Additions and/or revisions underlined:
…
What is APTIVUS?
APTIVUS is a prescription medicine used with ritonavir and other HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and children weighing 79 pounds (36 kg) or higher who:

have taken HIV-1 medicines in the past, and
whose healthcare provider determines that they meet certain requirements
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
…
Before taking APTIVUS, tell your healthcare provider about all of your medical conditions, including if you:
…

have a medical condition that increases your risk of bleeding, including trauma or surgery, or take medicines that increase your risk of bleeding, or take a high dose of vitamin E.
…

are breastfeeding or plan to breastfeed. It is not known if APTIVUS can pass into your breast milk. Talk to your healthcare provider about the following risks of breastfeeding during treatment with APTIVUS:
- The HIV-1 virus may pass to your baby if your baby does not have the HIV-1 infection
- The HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
- Your baby may get side effects from APTIVUS.
  …

06/18/2020 (SUPPL-21)

Approved Drug Label (PDF)

6 Adverse Reactions

(Table updated)

7 Drug Interactions

(Extensive changes; please refer to label)

09/15/2016 (SUPPL-16)

Approved Drug Label (PDF)

4 Contraindications

4.2 Drug Interactions (addition underlined)

Table 1: Drugs within Class that are Contraindicated with APTIVUS Co-administered with Ritonavir

Drug Class: Antipsychotics- Lurasidone

Clinical Comments: Potential for serious and/or life-threatening reactions.

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

Patient Information (addition underlined)

Who should not take APTIVUS?

Do not take APTIVUS if you:

• take any of the following types of medicines because you could have serious side effects:

o Latuda® (lurasidone)