Is Tymlos Safe? Risks, Benefits and Long Term Effects

What is Tymlos?

Tymlos is a medication used to treat osteoporosis in postmenopausal women who are at high risk of fractures. It helps increase bone density by stimulating bone formation. The active ingredient in Tymlos is abaloparatide and it is given as an injection under the skin.

Statistics About Tymlos

Here are some key statistics and information about Tymlos:

1. Efficacy Of Tymlos;
   • In clinical studies; Tymlos reduced the risk of vertebral fractures by about 86% compared to a placebo in postmenopausal women with osteoporosis.
   • It also reduced nonvertebral fractures by about 43%.
2. Bone Density Increase With Tymlos;
   • Tymlos has been shown to increase bone mineral density (BMD) in the spine by about 9-13% after 18 months of treatment.
   • Hip BMD increases by approximately 4-7% after the same period.
3. Administration Of Tymlos;
   • Tymlos is administered as a daily subcutaneous injection (under the skin) of 80 mcg.
   • Recommended treatment duration is up to 2 years.
4. Safety Of Tymlos;
   • Most common side effects are dizziness, headache, nausea and injection site reactions.
   • There is a black box warning for the risk of osteosarcoma (a type of bone cancer) based on animal studies but this risk has not been confirmed in humans.
5. Clinical Trial Data Of Tymlos;
   • ACTIVE Trial: In an 18-month, randomized, double-blind, placebo-controlled study involving 2,463 postmenopausal women with osteoporosis and Tymlos (80 mcg daily) demonstrated;
     • 9.2% increase in lumbar spine bone mineral density (BMD) compared to a 0.3% increase with placebo.
     • 3.4% increase in total hip BMD versus a 0.1% decrease with placebo.
     • 2.6% increase in femoral neck BMD compared to a 0.2% decrease with placebo.
     • 86% reduction in the risk of new vertebral fractures and a 43% reduction in nonvertebral fractures.
6. Real-World Data Of Tymlos;
   • Comparison with Teriparatide: In a real-world analysis of 43,352 women aged 50 and older with osteoporosis Tymlos;
     • Lower incidence of hip fractures compared to teriparatide.
     • Lower incidence of nonvertebral fractures compared to teriparatide.
7. Cost Of Tymlos;
   • Cost of Tymlos change but generally between $700 to $900 per month (depending on location, insurance and dosage).

What Are The Side Effects Of Tymlos?

Common Side Effects (occurring in >2% of patients) Of Tymlos

1. Dizziness;
   • This is one of the most commonly reported side effects. It may be particularly noticeable when standing up quickly because of orthostatic hypotension (a sudden drop in blood pressure when standing), which can cause to lightheadedness or fainting.
2. Headache;
   • This is another frequent side effect and may range from mild to moderate in intensity. It is usually temporary and resolves on its own as the body adjusts to the medication.
3. Nausea;
   • Gastrointestinal upset including nausea is relatively common. It often improves with continued use but in some cases it can be bothersome.
4. Injection site reactions;
   • These may pain, redness, swelling or itching at the site of the injection. Because of Tymlos is administered via daily subcutaneous injection, these local reactions are common with injectable medications but usually resolve on their own.
5. Fatigue;
   • Feeling of tiredness or fatigue has been reported by some patients. This can effect daily activities and may be more noticeable in the early stages of treatment.
6. Muscle cramps;
   • Some patients experience muscle cramps; could be seen in the arms, legs or other parts of the body and may be uncomfortable.
7. Back pain;
   • As Tymlos works to strengthen bones, some patients may experience increased discomfort in their back potentially as a result of changes in bone density.

Serious Side Effects Of Tymlos

1. Hypercalcemia (Elevated Calcium Levels);
   • Tymlos may lead to hypercalcemia (an increase in calcium levels in the blood).
     • Nausea
     • Vomiting
     • Constipation
     • Weakness
     • Confusion
     • Fatigue
     • Increased thirst and urination
   • If you experience any of these symptoms, you should notify your doctor immediately as elevated calcium levels can effect heart and kidney function.
2. Osteosarcoma (Bone Cancer);
   • Tymlos carries a black box warning regarding the potential risk of osteosarcoma (a rare form of bone cancer) based on findings in animal studies.
   • Osteosarcoma was observed in rats and mice treated with abaloparatide in preclinical studies. This raised concerns but relevance to humans is still unclear.
   • Risk of developing osteosarcoma in humans is unknown but doctors usually recommend Tymlos only when the benefits outweigh the risks especially for patients with existing bone conditions or high fracture risk.
3. Kidney Problems;
   • Kidney problems may arise in patients who experience hypercalcemia.
     • Kidney stones (caused by high calcium levels in the urine),
     • Decreased kidney function in severe cases of elevated calcium levels.
   • Monitoring kidney function and calcium levels is important. Especially for those with pre-existing kidney conditions.
4. Orthostatic Hypotension (Low Blood Pressure When Standing);
   • Tymlos can lead a drop in blood pressure when you stand up too quickly and cause to symptoms such as;
     • Dizziness
     • Lightheadedness
     • Fainting
   • This can be more common in the initial weeks of treatment.
5. Allergic Reactions;
   • Tymlos can cause serious allergic reactions (anaphylaxis) rarely. Symptoms are;
     • Rash
     • Swelling of the face, lips, or throat
     • Difficulty breathing
     • Tightness in the chest

Less Common Side Effects Of Tymlos

1. Hyperuricemia (Elevated Uric Acid);
   • Tymlos can increase levels of uric acid in the blood andcan cause to gout or joint pain in susceptible people. Gout is a type of arthritis caused by excess uric acid.
2. Elevated Blood Pressure;
   • Some patients experience an increase in blood pressure. Regular monitoring is recommended for people who already have hypertension or other cardiovascular risk factors.
3. Heart Palpitations;
   • Tymlos may lead to palpitations. Patients feel their heart beating unusually fast or strong. This could be related to the changes in calcium levels or a response to the injection.
4. Gastrointestinal Issues;
   • Although nausea is the most common issue Tymlos can also cause to; vomiting, diarrhea, abdominal pain or indigestion. These are usually mild and temporary.
5. Muscle Spasms;
   • Some patients report muscle spasms in various parts of the body. It can be painful and may require supportive treatments.
6. Joint Pain:
   • Some patients experience joint pain. It could be related to the strengthening of bones or other factors associated with the medication.

Monitoring During Treatment:

• Calcium levels should be monitored regularly because of Tymlos can lead to hypercalcemia. This is particularly important during the first few weeks of treatment.
• Kidney function should also be assessed regularly because high calcium levels may effect renal function.
• Blood pressure and heart rate should be monitored especially for people with existing cardiovascular issues.

What Are The Dosages Of Tymlos?

Standard Dosage Of Tymlos:

• 80 mcg (micrograms) once daily.

This is the typical dose for adult patients who are being treated for osteoporosis. Injection should be administered subcutaneously (under the skin) in areas such as the thigh or abdomen.

Administration Of Tymlos:

• Tymlos is given as a daily injection.
• It should be injected at the same time each day to help you don’t forget a dose.
• The injection site should be rotated daily to avoid irritation or bruising at the same spot.

Duration of Treatment Of Tymlos:

• Recommended treatment duration is up to 2 years.
• After 2 years of treatment with Tymlos your doctor may suggest transitioning to other osteoporosis treatments according to your response and treatment plan.

If You Miss a Dose Of Tymlos:

• If you miss a dose of tymlos; administer the dose as soon as you remember unless it’s almost time for your next dose. Don’t double the dose to make up for a missed one.
• Consult your doctor if you’re not sure about what to do.

Adjustments:

• In cases of severe kidney problems (e.g., renal impairment) dosage adjustments may be necessary and your doctor will guide you on the appropriate course of action.

We wish healthy and happy life to you. Also you can find details about treatment options and advices for Osteoporosis in below:

Osteoporosis 101: Symptoms, Causes, Treatment Options and Relationship With Ozempic.