Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions underlined:
TYMLOS is contraindicated in patients with a history
of severe hypersensitivity to abaloparatide or any
of the inactive ingredients of TYMLOS. Reactions have included
anaphylaxis, angioedema, dyspnea, and urticaria [see Warnings and Precautions (5.1), Adverse
Reactions (6.2)].
5
Warnings and Precautions
5.1 Hypersensitivity
Reactions
Newly added
subsection:
Hypersensitivity
reactions, including anaphylaxis, angioedema, and urticaria have been reported
in patients treated with parathyroid hormone (PTH) analogs, including TYMLOS [see Adverse Reactions (6.2)]. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with TYMLOS, initiate appropriate supportive care,
and monitor until signs and symptoms resolve.
Discontinue TYMLOS permanently in patients with a severe hypersensitivity reaction
to TYMLOS. TYMLOS is
contraindicated in patients with a history of severe hypersensitivity to
abaloparatide or any of the inactive ingredients of TYMLOS [see Contraindications (4)].
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
…
What is the most important information I should know about TYMLOS?
TYMLOS may cause serious side effects
including:
…
Who should not use FORTEO?
Do not use FORTEO if you:
…
Do not take TYMLOS:
…
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Advise the patient to read the FDA-approved patient
labeling (Medication Guide and Instructions for Use).
Hypersensitivity Reactions
Advise patients that serious
hypersensitivity reactions, including anaphylaxis, angioedema, and
urticaria, can occur with TYMLOS.
Advise patients to discontinue TYMLOS and promptly seek immediate medical attention if signs
or symptoms of hypersensitivity reactions occur [see Contraindications (4), Warnings
and Precautions (5.1)].
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
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.
. . .
. . .
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
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?
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:
…
How should I use
TYMLOS?
…
…
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)].
…
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