Tibsovo 250mg Tablets
WARNING: A health problem called differentiation syndrome has happened. This may cause organ problems and can be deadly. Call your doctor right away if you have bone pain, cough, fever, shortness of breath or other breathing problems, sudden weight gain, swelling in the arms or legs, or swollen gland. Call your doctor right away if you have signs of liver problems like dark urine or yellow skin or eyes; signs of kidney problems like unable to pass urine, change in amount of urine passed, or blood in the urine; or signs of low blood pressure like dizziness or passing out. @ COMMON USES: It is used to treat a type of leukemia. It is used to treat bile duct cancer.It is used to treat a health problem called myelodysplastic syndrome (MDS).
Drug Class
Antineoplastic agent, Isocitrate Dehydrogenase-1 (IDH1) inhibitor
Pharmacologic Class
Isocitrate Dehydrogenase-1 (IDH1) inhibitor
Pregnancy Category
Not available
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tibsovo is a medicine used to treat certain types of blood cancer (Acute Myeloid Leukemia or AML) and bile duct cancer (cholangiocarcinoma) in adults. It works by targeting a specific abnormal protein (IDH1) found in these cancers, which helps to slow down or stop the cancer cells from growing.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food, but try to avoid taking it with high-fat meals.
Swallow the medication whole - do not chew, break, or crush it.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
What to Do If You Vomit
If you vomit after taking a dose, do not take an extra dose. Instead, take your next dose at the usual time.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature in a dry place, away from the bathroom.
The medication bottle contains a desiccant to keep the medication dry. Leave the desiccant in the bottle and do not eat or swallow it.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (less than 12 hours away), skip the missed dose and take your next dose at the usual time. Do not take two doses within 12 hours of each other.
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food, but try to avoid taking it with high-fat meals.
Swallow the medication whole - do not chew, break, or crush it.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
What to Do If You Vomit
If you vomit after taking a dose, do not take an extra dose. Instead, take your next dose at the usual time.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature in a dry place, away from the bathroom.
The medication bottle contains a desiccant to keep the medication dry. Leave the desiccant in the bottle and do not eat or swallow it.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (less than 12 hours away), skip the missed dose and take your next dose at the usual time. Do not take two doses within 12 hours of each other.
Lifestyle & Tips
- Take Tibsovo exactly as prescribed by your doctor, usually once a day. You can take it with or without food, but try to take it consistently at the same time each day.
- Do not crush, chew, or split the tablets. Swallow them whole.
- Do not stop taking Tibsovo without talking to your doctor.
- Avoid grapefruit and grapefruit juice while taking Tibsovo, as they can increase the amount of medicine in your body.
- Inform your doctor about all other medications, vitamins, and herbal supplements you are taking, as some can interact with Tibsovo.
- Use effective contraception during treatment and for at least 2 months after the last dose if you are a woman of childbearing potential, or for at least 4 months after the last dose if you are a male with a female partner of childbearing potential.
- Avoid breastfeeding during treatment and for at least 1 month after the last dose.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
500 mg orally once daily
Dose Range:
500 - 500 mg
Condition-Specific Dosing:
Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation:
500 mg orally once daily until disease progression or unacceptable toxicity.
Cholangiocarcinoma with a susceptible IDH1 mutation:
500 mg orally once daily until disease progression or unacceptable toxicity.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required
Moderate:
No dose adjustment required
Severe:
No dose adjustment required
Dialysis:
No specific recommendations; Ivosidenib is highly protein-bound and unlikely to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment required
Moderate:
No dose adjustment required
Severe:
No specific dose adjustment recommended, but monitor patients with severe hepatic impairment for increased adverse reactions.
Pharmacology
Mechanism of Action
Ivosidenib is a small molecule inhibitor of mutant isocitrate dehydrogenase-1 (IDH1) enzyme. In cancer cells with IDH1 mutations, the enzyme produces high levels of the oncometabolite 2-hydroxyglutarate (2-HG). Ivosidenib works by inhibiting mutant IDH1, leading to a decrease in 2-HG levels. This reduction in 2-HG can restore normal cellular differentiation, particularly in myeloid cells in AML and in cholangiocarcinoma cells, thereby inhibiting tumor growth.
Pharmacokinetics
Absorption:
Bioavailability:
Not formally determined, but absorption is good.
Tmax:
3-4 hours (median)
FoodEffect:
Administration with a high-fat meal increased AUC by 48% and Cmax by 47% compared to fasting. Administration with a low-fat meal increased AUC by 23% and Cmax by 16%. May be taken with or without food, but consistently.
Distribution:
Vd:
Approximately 23.4 L (apparent volume of distribution)
ProteinBinding:
>99% (primarily to albumin and alpha-1-acid glycoprotein)
CnssPenetration:
Limited (low brain-to-plasma ratio observed in animal studies)
Elimination:
HalfLife:
Approximately 93 hours (mean terminal half-life)
Clearance:
Approximately 0.2 L/hr (apparent oral clearance)
ExcretionRoute:
Primarily fecal (approximately 78% of dose, with 28% as unchanged drug); approximately 10% excreted in urine (with 1% as unchanged drug).
Unchanged:
Approximately 28% (fecal), 1% (urine)
Pharmacodynamics
OnsetOfAction:
Not precisely defined, but clinical responses typically observed within weeks to months.
PeakEffect:
Reduction in 2-HG levels observed within days to weeks.
DurationOfAction:
Related to half-life and continued dosing; effects persist as long as treatment is continued.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
+ Change in balance
Other serious symptoms, including:
+ Swelling
+ Chest pain
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Fever, chills, or sore throat
Special Warnings for Patients with Cancer
If you have cancer and are taking this medication, you may be at a higher risk of developing a severe health condition called tumor lysis syndrome (TLS), which can be life-threatening. Contact your doctor immediately if you experience:
Fast or abnormal heartbeat
Passing out
Trouble urinating
Muscle weakness or cramps
Upset stomach, vomiting, diarrhea, or loss of appetite
Feeling sluggish
Additional Serious Side Effects
A type of abnormal heartbeat (prolonged QT interval) can occur with this medication. Seek medical help right away if you experience:
+ Fast heartbeat
+ Abnormal heartbeat
+ Passing out
A nervous system problem called Guillain-Barre syndrome has rarely occurred with this medication. Contact your doctor immediately if you experience:
+ Weakness
+ Changes in senses (such as vision, touch, hearing, or taste)
+ Trouble breathing
+ Abnormal burning, numbness, pain, or tingling sensations
Common Side Effects
Not all side effects are severe, and many people may experience only minor or no side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Feeling tired
Muscle or joint pain
Mouth irritation or mouth sores
Stomach pain
Decreased appetite
Weight loss
Headache
Trouble sleeping
Pimples (acne)
Constipation, diarrhea, vomiting, and upset stomach (common with this medication)
If these side effects occur, talk to your doctor about ways to manage them. If they are severe, bother you, or do not go away, seek medical help right away.
Reporting Side Effects
If you have questions about side effects or want to report any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
+ Change in balance
Other serious symptoms, including:
+ Swelling
+ Chest pain
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Fever, chills, or sore throat
Special Warnings for Patients with Cancer
If you have cancer and are taking this medication, you may be at a higher risk of developing a severe health condition called tumor lysis syndrome (TLS), which can be life-threatening. Contact your doctor immediately if you experience:
Fast or abnormal heartbeat
Passing out
Trouble urinating
Muscle weakness or cramps
Upset stomach, vomiting, diarrhea, or loss of appetite
Feeling sluggish
Additional Serious Side Effects
A type of abnormal heartbeat (prolonged QT interval) can occur with this medication. Seek medical help right away if you experience:
+ Fast heartbeat
+ Abnormal heartbeat
+ Passing out
A nervous system problem called Guillain-Barre syndrome has rarely occurred with this medication. Contact your doctor immediately if you experience:
+ Weakness
+ Changes in senses (such as vision, touch, hearing, or taste)
+ Trouble breathing
+ Abnormal burning, numbness, pain, or tingling sensations
Common Side Effects
Not all side effects are severe, and many people may experience only minor or no side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Feeling tired
Muscle or joint pain
Mouth irritation or mouth sores
Stomach pain
Decreased appetite
Weight loss
Headache
Trouble sleeping
Pimples (acne)
Constipation, diarrhea, vomiting, and upset stomach (common with this medication)
If these side effects occur, talk to your doctor about ways to manage them. If they are severe, bother you, or do not go away, seek medical help right away.
Reporting Side Effects
If you have questions about side effects or want to report any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Differentiation Syndrome: Fever, cough, trouble breathing, rapid weight gain, swelling (especially in legs/ankles), rash, bone pain, dizziness, feeling faint. These symptoms can be serious and require immediate medical attention.
- Heart problems (QTc prolongation): Feeling lightheaded, dizzy, fainting, or having a fast or irregular heartbeat. Report these immediately.
- Electrolyte imbalances: Muscle weakness, cramps, fatigue, irregular heartbeats.
- Liver problems: Yellowing of skin or eyes (jaundice), dark urine, severe nausea or vomiting, pain in the upper right side of your stomach.
- Infections: Fever, chills, sore throat, body aches, unusual tiredness.
- Numbness, tingling, or weakness in your arms or legs (signs of Guillain-Barré syndrome, a rare but serious side effect).
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 and its symptoms.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This medication can interact with various drugs, such as those used to treat HIV, infections, or seizures.
If you are breastfeeding. You should not breastfeed while taking this medication or for 1 month after your last dose.
Please note that this is not an exhaustive list of all potential interactions or health problems associated with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without consulting your doctor first.
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 and its symptoms.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This medication can interact with various drugs, such as those used to treat HIV, infections, or seizures.
If you are breastfeeding. You should not breastfeed while taking this medication or for 1 month after your last dose.
Please note that this is not an exhaustive list of all potential interactions or health problems associated with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. As directed by your doctor, you will need to undergo regular blood tests and electrocardiograms (ECGs) to monitor your heart rhythm.
If you have diabetes or high blood sugar, consult your doctor, as this medication may increase your blood sugar levels. Be aware of the signs of high blood sugar, which can include confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. If you experience any of these symptoms, notify your doctor promptly.
This medication may suppress the bone marrow's ability to produce essential blood cells, potentially leading to bleeding problems, infections, or anemia if your blood cell counts become severely low. If you have concerns or questions, discuss them with your doctor.
When taking this medication, it is crucial to use effective birth control methods, as birth control pills and other hormone-based contraceptives may not be reliable in preventing pregnancy. Consider using an additional form of birth control, such as condoms, to minimize the risk of pregnancy. Additionally, this medication may affect fertility, which could impact your ability to conceive or father a child. If you plan to become pregnant or father a child, consult your doctor before starting this medication.
This medication can pose a risk to an unborn baby. If you are pregnant or may become pregnant, it is vital to use birth control while taking this medication. If you become pregnant, notify your doctor immediately.
If you have diabetes or high blood sugar, consult your doctor, as this medication may increase your blood sugar levels. Be aware of the signs of high blood sugar, which can include confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. If you experience any of these symptoms, notify your doctor promptly.
This medication may suppress the bone marrow's ability to produce essential blood cells, potentially leading to bleeding problems, infections, or anemia if your blood cell counts become severely low. If you have concerns or questions, discuss them with your doctor.
When taking this medication, it is crucial to use effective birth control methods, as birth control pills and other hormone-based contraceptives may not be reliable in preventing pregnancy. Consider using an additional form of birth control, such as condoms, to minimize the risk of pregnancy. Additionally, this medication may affect fertility, which could impact your ability to conceive or father a child. If you plan to become pregnant or father a child, consult your doctor before starting this medication.
This medication can pose a risk to an unborn baby. If you are pregnant or may become pregnant, it is vital to use birth control while taking this medication. If you become pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established but may include exaggerated adverse effects such as QTc prolongation, differentiation syndrome, or gastrointestinal disturbances.
What to Do:
In case of overdose, contact your poison control center at 1-800-222-1222 or seek emergency medical attention immediately. Management should be supportive, including monitoring of ECG and electrolytes.
Drug Interactions
Major Interactions
- Strong CYP3A4 Inducers (e.g., Rifampin, Carbamazepine, Phenytoin, St. John's Wort): May significantly decrease ivosidenib exposure, reducing efficacy. Avoid coadministration.
- Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Clarithromycin, Ritonavir): May significantly increase ivosidenib exposure, increasing risk of adverse reactions. Avoid coadministration or reduce ivosidenib dose if unavoidable.
Moderate Interactions
- Moderate CYP3A4 Inducers (e.g., Efavirenz, Bosentan, Etravirine): May decrease ivosidenib exposure. Monitor for reduced efficacy.
- Moderate CYP3A4 Inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Grapefruit juice): May increase ivosidenib exposure. Monitor for increased adverse reactions.
- QTc-prolonging drugs (e.g., Class IA and III antiarrhythmics, Fluoroquinolones, Azole antifungals, Ondansetron): Ivosidenib can prolong QTc interval; coadministration may increase risk of Torsade de Pointes. Avoid or use with caution and monitor ECG and electrolytes.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline QTc interval, as Ivosidenib can prolong QTc.
Timing: Prior to initiation
Serum Electrolytes (Potassium, Magnesium, Calcium)
Rationale: To correct any abnormalities prior to treatment, as electrolyte imbalances can exacerbate QTc prolongation.
Timing: Prior to initiation
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: To assess baseline hepatic function and monitor for drug-induced liver injury.
Timing: Prior to initiation
Renal Function Tests (Creatinine, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and monitor for cytopenias.
Timing: Prior to initiation
Routine Monitoring
Electrocardiogram (ECG)
Frequency: Weekly for the first 3 weeks, then at least monthly for the first 3 months, and periodically thereafter.
Target: QTc < 480 ms (or < 500 ms if baseline is > 480 ms)
Action Threshold: QTc > 500 ms or increase of > 60 ms from baseline: Hold dose, correct electrolytes, re-evaluate. QTc > 500 ms with Torsade de Pointes or polymorphic ventricular tachycardia: Permanently discontinue.
Serum Electrolytes (Potassium, Magnesium, Calcium)
Frequency: Weekly for the first 3 weeks, then at least monthly for the first 3 months, and periodically thereafter. Correct abnormalities promptly.
Target: Within normal limits
Action Threshold: Abnormalities should be corrected prior to and during treatment.
Liver Function Tests (ALT, AST, Bilirubin)
Frequency: Weekly for the first month, then monthly for the next 2 months, and periodically thereafter.
Target: Within normal limits or stable
Action Threshold: Elevations > 3-5x ULN: Dose interruption/reduction may be required.
Complete Blood Count (CBC) with differential
Frequency: Weekly for the first month, then monthly for the next 2 months, and periodically thereafter.
Target: Within normal limits or stable
Action Threshold: Significant cytopenias may require dose interruption/reduction.
Symptom Monitoring
- Differentiation Syndrome (DS): Fever, dyspnea, weight gain, peripheral edema, rash, bone pain, dizziness, hypotension, pleural/pericardial effusion, renal dysfunction, hepatic dysfunction. Monitor closely, especially during the first 3 months. Initiate corticosteroids (e.g., dexamethasone) promptly if suspected.
- QTc prolongation symptoms: Dizziness, lightheadedness, syncope, palpitations, chest pain.
- Electrolyte imbalance symptoms: Muscle weakness, cramps, fatigue, irregular heartbeats.
- Gastrointestinal symptoms: Nausea, diarrhea, vomiting, abdominal pain.
- Infection symptoms: Fever, chills, sore throat, unusual fatigue.
- Neurological symptoms: Guillain-Barré syndrome (rare, but reported in clinical trials).
Special Patient Groups
Pregnancy
Based on animal studies and its mechanism of action, Tibsovo can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment and for at least 2 months after the last dose.
Trimester-Specific Risks:
First Trimester:
Potential for major congenital malformations and early embryonic death based on animal data.
Second Trimester:
Potential for adverse developmental outcomes based on animal data.
Third Trimester:
Potential for adverse developmental outcomes and effects on fetal growth based on animal data.
Lactation
It is not known if Ivosidenib is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment with Tibsovo and for at least 1 month after the last dose.
Infant Risk:
High (L5 - Contraindicated)
Pediatric Use
The safety and effectiveness of Tibsovo in pediatric patients have not been established.
Geriatric Use
No dose adjustment is required for elderly patients. Clinical studies included patients 65 years and older, and no overall differences in safety or effectiveness were observed between these patients and younger patients.
Clinical Information
Clinical Pearls
- Differentiation Syndrome (DS) is a critical adverse event. Educate patients on symptoms and emphasize immediate reporting. Have corticosteroids (e.g., dexamethasone) readily available for prompt initiation if DS is suspected.
- Monitor ECG and electrolytes (K, Mg, Ca) closely, especially during the first few months of treatment, due to the risk of QTc prolongation. Correct electrolyte abnormalities before and during treatment.
- Ivosidenib is a substrate of CYP3A4. Avoid coadministration with strong CYP3A4 inhibitors or inducers. If unavoidable, dose adjustments or close monitoring are necessary.
- Patients should be advised to take Tibsovo consistently with or without food, but not to switch between fed and fasted states, to maintain consistent drug exposure.
- For patients with AML, monitor for signs of leukocytosis, which may require treatment with hydroxyurea or other cytoreductive agents.
Alternative Therapies
- For IDH1-mutated AML: Chemotherapy (e.g., Azacitidine, Venetoclax + Azacitidine), other targeted therapies (e.g., Enasidenib for IDH2-mutated AML).
- For IDH1-mutated Cholangiocarcinoma: Chemotherapy (e.g., Gemcitabine + Cisplatin), other targeted therapies (e.g., FGFR inhibitors for FGFR2-fusion positive cholangiocarcinoma), immunotherapy.
Cost & Coverage
Average Cost:
$25,000 - $35,000+ per 30 tablets
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
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 details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
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 details about the medication taken, the amount, and the time it occurred.