megatope
Megatope (Albumin Iodinated I-131 Serum) is a medication supplied as an injection, solution.
Albumin Iodinated I-131 Serum · by Iso Tex
Key facts
- Active ingredient
- Albumin Iodinated I-131 Serum
- Form
- Injectable
- Strength
- Albumin Iodinated I-131 Serum 0.5mCi/VIAL · Albumin Iodinated I-131 Serum 1mCi/VIAL · Albumin Iodinated I-131 Serum 20uCi/AMP · Albumin Iodinated I-131 Serum 2mCi/VIAL · Albumin Iodinated I-131 Serum 5uCi/AMP
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Iso Tex
- FDA application
- BLA017837
What is Megatope?
From the FDA label:Chemical Characteristics MEGATOPE (iodinated I 131 albumin) injection is a sterile, nonpyrogenic, radioactive diagnostic agent for intravenous use. Each mL contains albumin human (approximately 10 mg), dibasic sodium phosphate (16 mg), guanidine hydrochloride (not more than 0.4 mg), monobasic sodium phosphate (1.6 mg), sodium chloride for isotonicity, and benzyl alcohol (9 mg) as a preservative. The stabilizers acetyltryptophanate and sodium caprylate have a concentration of less than 0.89 mM. The pH has been adjusted to 7.2 to 7.8 with sodium hydroxide or hydrochloric acid. Each vial contains 37 MBq/mL (1,000 microCi/mL) of radioactivity as iodinated I 131 albumin at time of calibration (see HOW SUPPLIED). Physical Characteristics Iodine-131 decays by beta and gamma emissions with a physical half-life of 8.02 days. Photons that are useful for detection and imaging studies are listed in Table 1. 1 Evaluated Nuclear Structure Data File of the Oak Ridge Nuclear Data Project DOE (1985). External Radiation The specific gamma ray constant for iodine-131 is 2.2 R/hour-millicurie at 1 cm. The first half-value layer is 0.24 cm lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that result from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from this radionuclide, the…
How to use
Premedication Administer 10 drops of Strong Iodine Solution, USP (e.g., Lugol’s Solution) three times daily, beginning at least 24 hours before administration of MEGATOPE and continue for 1 week or 2 weeks thereafter to minimize the uptake of iodine-131. Recommended Dosage The recommended dose of MEGATOPE for total blood or plasma volume determination in adult patients is from 0.185 MBq to 1.85 MBq (5 microCi to 50 microCi) administered intravenously. When a procedure such as a blood volume is to be repeated, do not exceed 7.4 MBq (200 microCi) in any 1 week. Administration Instructions • Measure the patient dose using a suitable dose calibrator immediately prior to administration. • Use a shielded syringe for withdrawing and injecting MEGATOPE. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. MEGATOPE is a colorless to very pale yellow solution. Do not use MEGATOPE if excessive coloration is present. • The expiration date given on the MEGATOPE vial label pertains to the stability of MEGATOPE and not to the radioactivity level. Blood Volume Determination Preparation of Reference Solution 1. Remove the amount from the vial to be used in the procedure identical in volume to the dose to be administered to the patient. 2. Prepare a reference solution using 0.9% Sodium…
Side effects
The following adverse reactions have been identified with the use of radioiodinated albumin products. 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. Immune System Disorders: Hypersensitivity
Warnings
Important safety information
Aseptic meningitis and pyrogenic reactions have been reported following cisternography with MEGATOPE. The safety and effectiveness of MEGATOPE for cisternography have not been established. MEGATOPE is not approved for this use.
Who should not take Megatope
None Known.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- Is there a coupon or discount for Megatope?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Megatope. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Megatope?
- Megatope is marketed by Iso Tex. You can see Iso Tex's full profile, rating, and other products on pharmaranks.
- Is Megatope a brand-name or generic drug?
- Megatope is a brand-name product with the active ingredient Albumin Iodinated I-131 Serum.
- Is Megatope available over the counter?
- No. Megatope is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Megatope come in?
- Megatope is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Megatope FDA-registered?
- Megatope is on record with the U.S. FDA under application number BLA017837. You can verify this on its official FDA label.
- Is Megatope safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Megatope. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Megatope?
- Megatope's side effects are taken directly from its FDA label. From the label: The following adverse reactions have been identified with the use of radioiodinated albumin products. Because these reactions are reported voluntarily from a population of uncertain size,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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