Digoxin immune FAB

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever;
• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
• shortness of breath (even with mild exertion); or
• swelling, rapid weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If possible, before you receive digoxin immune FAB, tell your doctor if you have:

• heart disease;

• kidney disease;

• if you are allergic to antibiotics; or

• if you are allergic to papaya extracts such as papain or chymopapain (Chymodiactin).

FDA pregnancy category C. It is not known whether digoxin immune FAB will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether digoxin immune FAB passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Usual Adult Dose for Digitalis Glycoside Toxicity:

Unknown amount of ingestion: 800 mg IV infusion if acute ingestion, 240 mg IV infusion if chronic ingestion.

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Dosing based on Serum Level:
Digoxin: Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).
Digitoxin: Dose (in # of vials) = (Serum digitoxin level in ng/mL) x (weight in kg) / (1000).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.

Usual Pediatric Dose for Digitalis Glycoside Toxicity:

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Children less than or equal to 20 kg: Dilution of reconstituted vial to 1 mg/mL may be desirable for doses of 3 mg or less.
Dose ( in # of mg) = Dose (in # vials) x 38 mg/vial.
Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection. The vial may be reconstituted and administered undiluted using a tuberculin syringe in infants and small children requiring small doses.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.

• If you have an allergy to digoxin immune Fab, sheep products, or any other part of digoxin immune fab.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about digoxin immune fab, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about digoxin immune fab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using digoxin immune fab.

Review Date: October 4, 2017

• DigiFab

Each vial of digoxin immune Fab 40 mg will bind ~0.5 mg of digoxin.

Digoxin toxicity: Note: Estimation of the dose is based on the body burden of digitalis. This may be calculated if the amount ingested is known or the post-distribution serum drug level is known (round the dose up to the nearest whole vial). If the amount ingested is unknown, general dosing guidelines should be used.

Acute ingestion of unknown amount: IV: Refer to adult dosing.

Acute ingestion of known amount: IV: Refer to adult dosing.

Based on steady-state serum digoxin concentration:

Infants and Children ≤20 kg: May require smaller doses; calculate the dose in milligrams (mg).

Digoxin Immune Fab Dose (mg) = [(serum digoxin concentration [ng/mL] x weight [kg]) / 100] x (digoxin immune Fab amount per vial [mg/vial])

Note: Digoxin immune Fab amount per vial: 40 mg/vial.

Alternatively, the following table gives an estimation of the amount of digoxin immune Fab needed based on the steady-state serum digoxin concentration.

Table has been converted to the following text.

Infants and Small Children Dose Estimates of Digoxin Immune Fab (in mg) From Steady-State Serum Digoxin Concentration

Based on Patient Weight in Kilograms

Patient Weight (kg): Serum Digoxin Concentration (ng/mL): Digoxin Immune Fab dose (mg)

1 kg

1 ng/mL: 0.4 mg1

2 ng/mL: 1 mg1

4 ng/mL: 1.5 mg1

8 ng/mL: 3 mg1

12 ng/mL: 5 mg

16 ng/mL: 6.5 mg

20 ng/mL: 8 mg

3 kg

1 ng/mL: 1 mg1

2 ng/mL: 2.5 mg1

4 ng/mL: 5 mg

8 ng/mL: 10 mg

12 ng/mL: 14 mg

16 ng/mL: 19 mg

20 ng/mL: 24 mg

5 kg

1 ng/mL: 2 mg1

2 ng/mL: 4 mg

4 ng/mL: 8 mg

8 ng/mL: 16 mg

12 ng/mL: 24 mg

16 ng/mL: 32 mg

20 ng/mL: 40 mg

10 kg

1 ng/mL: 4 mg

2 ng/mL: 8 mg

4 ng/mL: 16 mg

8 ng/mL: 32 mg

12 ng/mL: 48 mg

16 ng/mL: 64 mg

20 ng/mL: 80 mg

20 kg

1 ng/mL: 8 mg

2 ng/mL: 16 mg

4 ng/mL: 32 mg

8 ng/mL: 64 mg

12 ng/mL: 96 mg

16 ng/mL: 128 mg

20 ng/mL: 160 mg

1Dilution of reconstituted vial to 1 mg/mL may be desirable.

Children >20 kg and Adolescents: Refer to adult dosing.

Chronic toxicity (serum digoxin concentration unavailable): IV:

Infants and Children <20 kg: 1 vial is adequate to reverse most cases of toxicity

Children ≥20 kg and Adolescents: Refer to adult dosing.

Digoxin immune fab may interfere with digitalis immunoassay measurements, thereby resulting in clinically misleading total serum digoxin concentrations until all Fab fragments are eliminated from the body (may take several days to >1 week after administration). Digoxin serum samples should be obtained before digoxin immune fab administration, if possible.

Frequency not defined.

Cardiovascular: Orthostatic hypotension, phlebitis, ventricular tachycardia (patients with atrial fibrillation; due to digoxin withdrawal), worsening of heart failure (due to digoxin withdrawal)

Endocrine & metabolic: Hypokalemia

Hypersensitivity: Hypersensitivity reaction, serum sickness

Close monitoring of temperature, blood pressure, ECG, and serum potassium is recommended. Hypokalemia may develop rapidly.