Tymlos Inj, 1 Prefilled Pen
It is used to treat soft, brittle bones (osteoporosis) after menopause.It is used to treat soft, brittle bones (osteoporosis) in men who have a high risk of breaking a bone.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Parathyroid hormone related protein analog
Pharmacologic Class
Bone formation agent; Selective parathyroid hormone 1 receptor (PTH1R) agonist
Pregnancy Category
Not available
FDA Approved
Apr 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tymlos is an injectable medicine used to treat osteoporosis in women after menopause who are at high risk of breaking bones. It works by helping your body build new bone, making your bones stronger and less likely to fracture. You inject it under your skin once a day for up to two years.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and try to take it at the same time every day. If you experience dizziness or feel like passing out, you may need to take your medication while sitting or lying down. Discuss this with your doctor.
This medication is administered via injection into the fatty tissue of the abdominal area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. On the first day, you will need to prime the pen as instructed. However, do not prime the pen on days 2 through 30, as this can result in wasted medication.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color. Never transfer the medication from the pen to a syringe. Rotate the injection site with each dose, avoiding areas within 2 inches (5 cm) of the belly button. Also, avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposing of Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store the medication in the refrigerator until first use. After opening, store at room temperature. Discard any unused medication after 30 days. Protect the medication from heat.
Missing a Dose
If you miss a dose, take it as soon as you remember on the same day. If you don't remember until the next day, skip the missed dose and resume your regular schedule. Do not take more than one dose of this medication in a 24-hour period.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and try to take it at the same time every day. If you experience dizziness or feel like passing out, you may need to take your medication while sitting or lying down. Discuss this with your doctor.
This medication is administered via injection into the fatty tissue of the abdominal area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. On the first day, you will need to prime the pen as instructed. However, do not prime the pen on days 2 through 30, as this can result in wasted medication.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color. Never transfer the medication from the pen to a syringe. Rotate the injection site with each dose, avoiding areas within 2 inches (5 cm) of the belly button. Also, avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposing of Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store the medication in the refrigerator until first use. After opening, store at room temperature. Discard any unused medication after 30 days. Protect the medication from heat.
Missing a Dose
If you miss a dose, take it as soon as you remember on the same day. If you don't remember until the next day, skip the missed dose and resume your regular schedule. Do not take more than one dose of this medication in a 24-hour period.
Lifestyle & Tips
- Ensure adequate intake of calcium and vitamin D through diet or supplements, as recommended by your doctor.
- Engage in regular weight-bearing exercise, such as walking or jogging, to help maintain bone strength.
- Avoid smoking and excessive alcohol consumption, as these can negatively impact bone health.
- Learn proper injection technique from your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
80 mcg subcutaneously once daily
Dose Range:
80 - 80 mg
Condition-Specific Dosing:
postmenopausal_osteoporosis:
80 mcg subcutaneously once daily for a maximum of 2 years
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary, but caution advised due to limited data
Dialysis:
No specific recommendations; caution advised due to limited data
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Pharmacology
Mechanism of Action
Abaloparatide is a synthetic analog of human parathyroid hormone-related protein (PTHrP) that acts as a selective agonist for the PTH1 receptor. It preferentially stimulates the signaling pathway associated with bone formation (anabolic effects) when administered intermittently, leading to increased bone mineral density and reduced fracture risk.
Pharmacokinetics
Absorption:
Bioavailability:
36%
Tmax:
0.5 hours
FoodEffect:
Not applicable (subcutaneous injection)
Distribution:
Vd:
50 L
ProteinBinding:
Not extensively bound to plasma proteins
CnssPenetration:
Limited
Elimination:
HalfLife:
1.7 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily as peptide fragments)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose, reflected in biochemical markers)
PeakEffect:
Not directly quantifiable for bone density, but biochemical markers of bone formation peak within weeks to months.
DurationOfAction:
Effects on bone mineral density persist after discontinuation, but the anabolic effect requires continued administration. Treatment duration is limited to 2 years.
Safety & Warnings
BLACK BOX WARNING
In male and female rats, abaloparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) at exposures 4 to 28 times the human exposure. It is unknown whether Tymlos will cause osteosarcoma in humans. Use of Tymlos is for a maximum of 2 years during a patient’s lifetime.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Severe dizziness or fainting
Feeling like you are spinning
Fast or abnormal heartbeat
Shortness of breath
Muscle weakness
Back pain, belly pain, or blood in the urine, which may be signs of a kidney stone
Pain when passing urine
This medication has been associated with a higher rate of bone cancer in animal studies. Although this increased risk has not been confirmed in human studies, it is essential to report any unusual symptoms to your doctor. If you experience bone pain, persistent pain, or a tender lump or swelling under your skin, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is crucial to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Feeling dizzy, tired, or weak
Upset stomach
Headache
Stomach pain
Diarrhea
Joint pain
Bloating
* Pain, redness, swelling, or other reaction at the injection site
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Severe dizziness or fainting
Feeling like you are spinning
Fast or abnormal heartbeat
Shortness of breath
Muscle weakness
Back pain, belly pain, or blood in the urine, which may be signs of a kidney stone
Pain when passing urine
This medication has been associated with a higher rate of bone cancer in animal studies. Although this increased risk has not been confirmed in human studies, it is essential to report any unusual symptoms to your doctor. If you experience bone pain, persistent pain, or a tender lump or swelling under your skin, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is crucial to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Feeling dizzy, tired, or weak
Upset stomach
Headache
Stomach pain
Diarrhea
Joint pain
Bloating
* Pain, redness, swelling, or other reaction at the injection site
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of high calcium (hypercalcemia): nausea, vomiting, constipation, low energy, muscle weakness.
- Dizziness or lightheadedness, especially when standing up (orthostatic hypotension), usually within 4 hours of injection.
- New or unusual bone pain, which could be a sign of osteosarcoma (though rare and not confirmed in humans).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
Certain health conditions, such as:
+ High calcium levels in your blood
+ An overactive parathyroid gland
If you are at risk for osteosarcoma, a type of bone cancer. This may include:
+ Having Paget's disease
+ Experiencing bone problems other than osteoporosis
+ Having bones that have not yet stopped growing
+ A history of bone cancer or radiation therapy to the bones
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in these situations. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
* If the patient is a child, as this medication is not intended for pediatric use.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
Certain health conditions, such as:
+ High calcium levels in your blood
+ An overactive parathyroid gland
If you are at risk for osteosarcoma, a type of bone cancer. This may include:
+ Having Paget's disease
+ Experiencing bone problems other than osteoporosis
+ Having bones that have not yet stopped growing
+ A history of bone cancer or radiation therapy to the bones
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in these situations. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
* If the patient is a child, as this medication is not intended for pediatric use.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize the risk of dizziness or fainting, stand up slowly when getting up from a sitting or lying down position, and exercise caution when climbing stairs.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. Additionally, have a bone density test performed as recommended by your doctor, and discuss the results with them. Take calcium and vitamin D supplements as instructed by your doctor.
Do not exceed the prescribed duration of treatment with this medication. It is crucial to use the pen or cartridge devices exclusively and not share them with others, even if the needle has been replaced. Sharing these devices can lead to the transmission of infections, including those that may be asymptomatic.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. Additionally, have a bone density test performed as recommended by your doctor, and discuss the results with them. Take calcium and vitamin D supplements as instructed by your doctor.
Do not exceed the prescribed duration of treatment with this medication. It is crucial to use the pen or cartridge devices exclusively and not share them with others, even if the needle has been replaced. Sharing these devices can lead to the transmission of infections, including those that may be asymptomatic.
Overdose Information
Overdose Symptoms:
- Exaggerated effects of the drug, including hypercalcemia (nausea, vomiting, constipation, lethargy, muscle weakness)
- Orthostatic hypotension (dizziness, lightheadedness, fainting)
What to Do:
Seek immediate medical attention. Management is supportive, including hydration and monitoring of serum calcium. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Digoxin (potential for transient hypercalcemia, though not consistently observed clinically, may increase digoxin toxicity risk)
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure calcium levels are within normal range before initiating therapy and to monitor for hypercalcemia.
Timing: Before initiation of therapy
25-hydroxyvitamin D
Rationale: To ensure vitamin D sufficiency, as adequate vitamin D is important for bone health and to minimize risk of hypercalcemia.
Timing: Before initiation of therapy
Bone Mineral Density (BMD)
Rationale: To establish baseline bone health and assess treatment efficacy.
Timing: Before initiation of therapy
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if symptoms of hypercalcemia occur
Target: Normal range (e.g., 8.5-10.2 mg/dL)
Action Threshold: >10.5 mg/dL or symptomatic hypercalcemia; consider temporary discontinuation or further evaluation.
Bone Mineral Density (BMD)
Frequency: Typically after 1-2 years of treatment, or as clinically indicated
Target: Increase in BMD
Action Threshold: Lack of response or continued bone loss may warrant re-evaluation of therapy.
Symptom Monitoring
- Symptoms of hypercalcemia (nausea, vomiting, constipation, lethargy, muscle weakness)
- Injection site reactions (redness, swelling, bruising)
- Orthostatic hypotension (dizziness, lightheadedness, rapid heart rate upon standing)
Special Patient Groups
Pregnancy
Tymlos is not indicated for use in women of reproductive potential. It is generally not recommended during pregnancy due to potential risks to the fetus, though human data are lacking. Animal studies showed adverse effects on fetal development at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal data.
Second Trimester:
Potential for adverse developmental effects based on animal data.
Third Trimester:
Potential for adverse developmental effects based on animal data.
Lactation
It is unknown if abaloparatide is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during Tymlos treatment.
Infant Risk:
Potential for unknown adverse effects; L3 (moderately safe, but caution advised).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Tymlos is not indicated for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. No dose adjustment is necessary based on age.
Clinical Information
Clinical Pearls
- Tymlos is an anabolic agent for osteoporosis, meaning it builds new bone, unlike antiresorptive agents (e.g., bisphosphonates) which slow bone breakdown.
- The maximum duration of treatment is 2 years over a patient's lifetime due to the theoretical risk of osteosarcoma observed in animal studies.
- Patients should be instructed to administer the injection while sitting or lying down to minimize the risk of orthostatic hypotension, which can occur within 4 hours of injection.
- Adequate calcium and vitamin D intake are crucial for optimal response to abaloparatide.
- Consider sequential therapy: after completing 2 years of abaloparatide, patients should typically transition to an antiresorptive agent (e.g., bisphosphonate, denosumab) to maintain and further increase BMD gains.
Alternative Therapies
- Teriparatide (Forteo) - another anabolic agent (PTH analog)
- Romosozumab (Evenity) - a sclerostin inhibitor with dual action (bone formation and reduced resorption)
- Bisphosphonates (e.g., alendronate, risedronate, zoledronic acid) - antiresorptive agents
- Denosumab (Prolia) - antiresorptive agent (RANKL inhibitor)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene) - antiresorptive agents
Cost & Coverage
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.