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.

TYMLOS (NDA-208743)

(ABALOPARATIDE)

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

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12/19/2022 (SUPPL-13)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes due to a new indication in men with osteoporosis; please refer to label

8 Use in Specific Populations

8.5 Geriatric Use

Additions and revisions underlined:

Of the total number of patients in the postmenopausal osteoporosis clinical studies of TYMLOS, 82% were age 65 years and over, and 19% were age 75 years and over. In the male osteoporosis study, 74% were age 65 years and over and 23% were age 75 years or over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

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

Medication Guide

Additions and revisions underlined:

. . .

TYMLOS is a prescription medicine used to:

treat osteoporosis in postmenopausal women who are at high risk for bone fracture, or who cannot use another osteoporosis treatment or other osteoporosis treatments did not work well. TYMLOS can decrease the chance of having a fracture of the spine and other bones in postmenopausal women with thinning and weakening bones (osteoporosis)
increase bone density in men with osteoporosis who are at high risk for bone fracture, or who cannot use another osteoporosis treatment or other osteoporosis treatments did not work well

. . .

The most common side effects of TYMLOS in men with osteoporosis include:

• redness at injection site • pain at injection site • nausea

• dizziness • bruising • abdominal pain

• joint pain • abdominal bloating • bone pain

• swelling at injection site • diarrhea

12/22/2021 (SUPPL-10)

Approved Drug Label (PDF)

Boxed Warning

Effective 12/2021, Box Warning in supplement 10 has been removed

5 Warnings and Precautions

5.1 Risk of Osteosarcoma

Additions and/or revisions underlined:

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4 to 28 times the human exposure at the clinical dose of 80 mcg [see Nonclinical Toxicology (13.1)]. It is unknown whether TYMLOS will cause osteosarcoma in humans.

Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS and/or use of a PTH-analog [see Dosage and Administration (2.3) and Nonclinical Toxicology (13.1)].

Avoid TYMLOS use in patients with (these patients are at increased baseline risk of osteosarcoma):

Open epiphyses (pediatric and young adult patients) (TYMLOS is not approved in pediatric patients) [see Use in Specific Populations (8.4)].
Metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone.
Bone metastases or a history of skeletal malignancies.
Prior external beam or implant radiation therapy involving the skeleton.
Hereditary disorders predisposing to osteosarcoma.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

How should I use TYMLOS?

You should not use TYMLOS for more than 2 years over your lifetime.

10/23/2020 (SUPPL-7)

Approved Drug Label (PDF)

4 Contraindications

(Subsection revised, additions underlined)

TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea and urticaria [see Adverse Reactions (6.3)].

6 Adverse Reactions

6.3 Postmarketing Experience

(New subsection added)

The following adverse reactions have been identified during the post-approval use of TYMLOS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Abdominal distension, abdominal pain
Constipation, diarrhea, vomiting
Asthenia, lethargy, malaise
Insomnia
Hypersensitivity and anaphylactic reactions, dyspnea (in the context of allergic reactions)
Pruritus, rash
Generalized pain and pain in bone, joint, back, and extremity
Muscle spasms of the leg and back
Injection site reactions including bruising, hemorrhage, pruritus, and rash

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

MEDICATION GUIDE

(Additions underlined)

…

Do not take TYMLOS:

if you had an allergic reaction to abaloparatide, or any of the other ingredients in TYMLOS. See the end of this Medication Guide for a complete list of ingredients in TYMLOS.

…

How should I use TYMLOS?

…

Do not share your TYMLOS pen or pen needles with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

…

PATIENT COUNSELING INFORMATION

(Additions underlined)

…

Hypersensitivity Reactions

Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction including anaphylaxis, dyspnea or urticaria [see Contraindications (4) and Adverse Reactions (6.3)].

…