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.

TEKTURNA (NDA-021985)

(ALISKIREN HEMIFUMARATE)

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

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06/17/2020 (SUPPL-39)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

Tekturna is contraindicated in pediatric patients less than 2 years of age because of the risk of high aliskiren exposures identified in juvenile animals due to immaturity of transporters and metabolic enzymes [see Use in Specific Populations (8.4)].

8 Use in Specific Populations

Pediatric Use

(Extensive changes; please refer to label)

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

Patient Information

(Newly added section)

11/14/2017 (SUPPL-34)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

Tekturna is contraindicated in pediatric patients less than 2 years of age.

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined)

Adult Hypertension

Data described below reflect the evaluation of the safety of Tekturna in more than 6,460 patients, including over 1,740 treated for longer than 6 months, and more than 1,250 patients for longer than 1 year…

Pediatric Hypertension

Aliskiren has been evaluated for safety in 267 pediatric hypertensive patients 6 to 17 years of age; including 208 patients treated for 52 weeks. These studies did not reveal any unanticipated adverse reactions.

Adverse reactions in pediatric patients 6 years of age and older are expected to be similar to those seen in adults.

8 Use in Specific Populations

8.2 Lactation

(Additions and/or revisions are underlined)

…Because of the potential for serious adverse reactions, including hypotension, hyperkalemia and renal impairment in nursing infants, advise a nursing woman that breastfeeding is not recommended during treatment with Tekturna.

8.4 Pediatric Use

(Additions and/or revisions are underlined)

Safety and effectiveness have not been established in pediatric patients younger than 6 years.

The antihypertensive effects of Tekturna have been evaluated in two randomized, double-blind clinical studies in pediatric patients 6 to 17 years of age. The pharmacokinetics of Tekturna have been evaluated in pediatric patients 6 to 17 years of age. In this age group, the adverse event profile is expected to be similar to that in adults.

Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients. Because of the findings in these studies, Tekturna is contraindicated in children less than 2 years of age and should not be used in children 2 to less than 6 years of age.

No data are available in pediatric patients with a glomerular filtration rate <30 mL/min/1.73 m2.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information) and Instructions for Use.

Administration of Oral Pellets: Advise the patient or caregiver not to swallow capsules containing Tekturna oral pellets. Review administration instructions for Oral Pellets with the patient or caregiver.

11/04/2016 (SUPPL-31)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

The following adverse reactions have been reported in aliskiren postmarketing experience. addition of Hyponatremia

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

Tekturna can cause fetal harm when administerd to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue Tekturna as soon as possible.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2-4%, and 15-20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Fetal/Neonatal adverse reactions

Use of drugs that act on the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there …

In patients taking Tekturna during pregnancy, perform serial ultrasound examinations to assess the intra- amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware … If oliguria or hypotension occur in neonates with a history of in utero exposure to Tekturna, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function.

Data

Animal Data

In developmental toxicity studies, pregnant rats and rabbits received oral aliskiren hemifumarate during organogenesis at doses up to 20 and 7 times the maximum recommended human dose (MRHD) based on body surface area (mg/m2), respectively, in rats and rabbits. (Actual animal doses were up to 600 mg/kg/day in rats and up to 100 mg/kg/day in rabbits.) No teratogenicity was observed; however, fetal birth weight was decreased in rabbits at doses 3.2 times the MRHD based on body surface area (mg/m2). Aliskiren was present in placentas, amniotic fluid and fetuses of pregnant rabbits.

8.2 Lactation

(PLLR conversion)

There is no information regarding the presence of aliskiren in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including hypotension, hyperkalemia and renal impairment in nursing infants, advise a nursing woman that breastfeeding is not recommended during treatment with TEKTURNA.

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

Patient Counseling Information

Lactation (addition)

Advise nursing women that breastfeeding is not recommended during treatment with Tekturna.

Patient Information

Tekturna® (tek-turn-a) (aliskiren) Tablets

What Are Possible Side Effects of Tekturna?

Less common side effects include (addition of) low level of sodium in blood.