Megestrol Acetate 40mg/ml Susp

Megestrol acetate is a synthetic progestin with anti-estrogenic properties. Its exact mechanism of action in appetite stimulation and weight gain is not fully understood but is thought to involve modulation of cytokine production (e.g., TNF-alpha, IL-1, IL-6) and/or direct effects on the hypothalamus. In cancer, it exerts its antineoplastic effects primarily through anti-estrogenic activity by inhibiting the growth of hormone-sensitive tumors.

Serious 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 experience any of the following symptoms, contact your doctor immediately or seek 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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of high blood pressure, such as:
+ Very bad headache or dizziness
+ Passing out
+ Change in eyesight
Shortness of breath
Big weight gain
Swelling in the arms or legs
Vaginal bleeding that is not normal
Mood changes
Decreased interest in sex
Difficulty getting or keeping an erection
Fever
Pain or numbness in the hands or wrist
Worsening of your tumor (tumor flare reaction), which may cause:
+ Increased pain or tenderness where your tumor is
+ Hot flashes
+ Other symptoms
Blood clots, which may cause:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of your body
+ Trouble speaking or thinking
+ Change in balance
+ Change in eyesight
+ Shortness of breath
+ Swelling, warmth, or pain in the leg or arm

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. Many individuals experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:

Upset stomach or vomiting
Headache
Increased appetite
Weight gain
Trouble sleeping
Gas
Feeling tired or weak
Hair loss
Hot flashes
Sweating a lot
* Diarrhea

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

If you have a known allergy to megestrol acetate or any component of this medication. Describe the allergic reaction you experienced, including any symptoms that occurred.
If you are taking dofetilide, as this may interact with the medication.
If you are pregnant or think you may be pregnant. Do not use this medication to stimulate appetite if you are pregnant.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

One of the potential side effects of this drug is the development of high blood sugar, which may lead to new-onset diabetes or worsen existing diabetes. It is crucial to check your blood sugar levels as instructed by your doctor.

This medication may also affect your body's natural production of steroids. If you experience a severe infection, undergo surgery, or suffer an injury, notify your doctor immediately. Additionally, if you experience severe dizziness, fainting, persistent nausea and vomiting, or extreme fatigue and weakness, seek medical attention right away, as you may require steroid replacement therapy. Consult with your doctor to discuss the best course of action.

If you are pregnant or planning to become pregnant, it is vital to be aware that this drug may harm the unborn baby. Your doctor may require a pregnancy test before initiating treatment to confirm that you are not pregnant. To prevent pregnancy while taking this medication, use a reliable form of birth control. If you become pregnant or suspect you may be pregnant while taking this drug, contact your doctor immediately.

• Indinavir (decreased indinavir plasma concentrations)
• Warfarin (increased INR/bleeding risk)

• Other drugs metabolized by CYP3A4 (potential for altered metabolism, though megestrol is not a strong inducer/inhibitor)
• Corticosteroids (additive adrenal suppression risk with long-term high-dose megestrol)

• Signs of hyperglycemia (increased thirst, urination, fatigue)
• Signs of thromboembolism (leg pain/swelling, chest pain, shortness of breath)
• Signs of adrenal suppression (fatigue, weakness, dizziness, nausea, vomiting, hypotension)
• Fluid retention/edema
• Vaginal bleeding (in women)

Contraindicated in pregnancy (Category X). Megestrol acetate can cause fetal harm when administered to a pregnant woman. It is a progestational agent and should not be used during pregnancy.

Contraindicated during breastfeeding (L5). Megestrol acetate is excreted in human milk. Due to the potential for serious adverse reactions in the nursing infant, including effects on growth and development, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended due to potential for adverse effects on growth and development, including adrenal suppression. Limited data exist for specific indications (e.g., appetite stimulation in pediatric oncology patients) where benefits may outweigh risks, but careful monitoring is required.

No specific dose adjustment is generally needed based on age alone. However, elderly patients may be more susceptible to adverse effects such as thromboembolic events, fluid retention, and hyperglycemia. Monitor closely for these effects.

• Megestrol acetate oral suspension (40 mg/mL) has significantly higher bioavailability than the tablet formulation; doses are not interchangeable.
• For appetite stimulation, weight gain may not be apparent for several weeks (typically 8-12 weeks for maximal effect).
• Patients should be monitored for signs of adrenal suppression, especially after prolonged high-dose therapy or upon discontinuation, as withdrawal symptoms can occur.
• Increased risk of thromboembolic events (DVT, PE) should be considered, especially in patients with pre-existing risk factors.
• Hyperglycemia can occur, particularly in diabetic patients; monitor blood glucose levels.
• The 40 mg/mL suspension is often preferred for cachexia due to its higher concentration and improved absorption, allowing for smaller volumes for high doses.

• For appetite stimulation: Dronabinol, Mirtazapine, Ghrelin mimetics (e.g., Anamorelin - not FDA approved for cachexia in US, but approved elsewhere).
• For breast cancer: Tamoxifen, Aromatase inhibitors (e.g., Anastrozole, Letrozole, Exemestane), Fulvestrant, Chemotherapy.
• For endometrial carcinoma: Progestins (other forms), Chemotherapy.

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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.