Allergan France

Allergan France is an injectable antiviral medication for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. It suppresses CMV replication by selective inhibition of viral DNA synthesis. [Wikipedia]

Intravenous

Cytomegaloviral retinitis in AIDS patients

Adult: Induction: 5 mg/kg by infusion over 1 hr once wkly for 2 consecutive wk.

Maintenance: 5 mg/kg once every 2 wk, starting 2 wk after completion of induction treatment. Administer w/ oral probenecid 2 g, 3 hr prior to each Allergan France dose, further doses of 1 g at 2 and 8 hr after completion of infusion. Hydration: Infuse 1 L normal saline over 1-2 hr immediately before Allergan France infusion; if patient can tolerate additional water load, a 2nd liter may be given over 1-3 hr at the start of or immediately following infusion.

Renal impairment: Contraindicated.

Allergan France is an antiviral medication that prevents certain viral cells from multiplying in your body.

Allergan France is used to treat an eye infection called cytomegalovirus retinitis (CMV) in people who have AIDS (acquired immunodeficiency syndrome). Allergan France is not a cure for CMV or AIDS.

Allergan France is for treating CMV only in people who have AIDS.

Allergan France may also be used for purposes not listed in this medication guide.

Allergan France MUST NOT BE ADMINISTERED BY INTRAOCULAR INJECTION.

Dosage

THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATE MUST NOT BE EXCEEDED. Allergan France MUST BE DILUTED IN 100 MILLILITERS 0.9% (NORMAL) SALINE PRIOR TO ADMINISTRATION. TO MINIMIZE POTENTIAL NEPHROTOXICITY, PROBENECID AND INTRAVENOUS SALINE PREHYDRATION MUST BE ADMINISTERED WITH EACH Allergan France INFUSION.

Induction Treatment

The recommended induction dose of Allergan France for patients with a serum creatinine of ≤ 1.5 mg/dL, a calculated creatinine clearance > 55 mL/min, and a urine protein < 100 mg/dL (equivalent to < 2+ proteinuria) is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once weekly for two consecutive weeks. Because serum creatinine in patients with advanced AIDS and CMV retinitis may not provide a complete picture of the patient's underlying renal status, it is important to utilize the Cockcroft-Gault formula to more precisely estimate creatinine clearance (CrCl). As creatinine clearance is dependent on serum creatinine and patient weight, it is necessary to calculate clearance prior to initiation of Allergan France. CrCl (mL/min) should be calculated according to the following formula:

Maintenance Treatment

The recommended maintenance dose of Allergan France is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr), administered once every 2 weeks.

Dose Adjustment

Changes In Renal Function During Allergan France Therapy

The maintenance dose of Allergan France must be reduced from 5 mg/kg to 3 mg/kg for an increase in serum creatinine of 0.3 – 0.4 mg/dL above baseline. Allergan France therapy must be discontinued for an increase in serum creatinine of ≥ 0.5 mg/dL above baseline or development of ≥ 3+ proteinuria.

Preexisting Renal Impairment

Allergan France is contraindicated in patients with a serum creatinine concentration > 1.5 mg/dL, a calculated creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria).

Probenecid

Probenecid must be administered orally with each Allergan France dose. Two grams must be administered 3 hr prior to the Allergan France dose and one gram administered at 2 and again at 8 hr after completion of the 1 hr Allergan France infusion (for a total of 4 grams).

Ingestion of food prior to each dose of probenecid may reduce drug-related nausea and vomiting. Administration of an antiemetic may reduce the potential for nausea associated with probenecid ingestion. In patients who develop allergic or hypersensitivity symptoms to probenecid, the use of an appropriate prophylactic or therapeutic antihistamine and/or acetaminophen should be considered.

Hydration

Patients must receive at least one liter of 0.9% (normal) saline solution intravenously with each infusion of Allergan France. The saline solution should be infused over a 1–2 hr period immediately before the Allergan France infusion. Patients who can tolerate the additional fluid load should receive a second liter. If administered, the second liter of saline should be initiated either at the start of the Allergan France infusion or immediately afterwards, and infused over a 1 to 3 hr period.

Method Of Preparation And Administration

Inspect vials visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is observed, the vial should not be used. With a syringe, extract the appropriate volume of Allergan France from the vial and transfer the dose to an infusion bag containing 100 mL 0.9% (normal) saline solution. Infuse the entire volume intravenously into the patient at a constant rate over a 1 hr period. Use of a standard infusion pump for administration is recommended.

It is recommended that Allergan France infusion admixtures be administered within 24 hr of preparation and that refrigerator or freezer storage not be used to extend this 24 hr limit.

If admixtures are not intended for immediate use, they may be stored under refrigeration (2–8°C) for no more than 24 hr. Refrigerated admixtures should be allowed to equilibrate to room temperature prior to use.

The chemical stability of Allergan France admixtures was demonstrated in polyvinyl chloride composition and ethylene/propylene copolymer composition commercial infusion bags, and in glass bottles. No data are available to support the addition of other drugs or supplements to the Allergan France admixture for concurrent administration.

Allergan France is supplied in single-use vials. Partially used vials should be discarded.

Compatibility with Ringer's solution, Lactated Ringer's solution or bacteriostatic infusion fluids has not been evaluated.

Handling And Disposal

Due to the mutagenic properties of Allergan France, adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration, and disposal of Allergan France. The National Institutes of Health presently recommends that such agents be prepared in a Class II laminar flow biological safety cabinet and that personnel preparing drugs of this class wear surgical gloves and a closed front surgical-type gown with knit cuffs. If Allergan France contacts the skin, wash membranes and flush thoroughly with water. Excess Allergan France and all other materials used in the admixture preparation and administration should be placed in a leak-proof, puncture-proof container. The recommended method of disposal is high temperature incineration.

Patient Monitoring

Serum creatinine and urine protein must be monitored within 48 hours prior to each dose. White blood cell counts with differential should be monitored prior to each dose. In patients with proteinuria, intravenous hydration should be administered and the test repeated. Intraocular pressure, visual acuity and ocular symptoms should be monitored periodically.

How supplied

Allergan France (Allergan France injection) 75 mg/mL for intravenous infusion, is supplied as a non-preserved solution in single-use clear glass vials as follows:

NDC 61958-0101-1 375 mg in a 5 mL vial in a single-unit carton

Allergan France should be stored at controlled room temperature 20–25 °C (68–77 °F).

Allergan France (Allergan France injection) is covered by U.S. Patent No. 5,142,051 and its foreign counterparts. Other patents pending.

REFERENCES

1. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Allergan France for the Treatment of Cytomegalovirus Retinitis in Patients with AIDS: the Allergan France Peripheral Cytomegalovirus Retinitis Trial. Ann Intern Med 126:264–274, 1997.

2. Lalezari JP, Stagg RJ, Kupperman BD, et al.

Intravenous Allergan France for Peripheral Cytomegalovirus Retinitis in Patients with AIDS. A Randomized, Controlled Trial. Ann Intern Med 126:257–263, 1997.

Distributed by: Gilead Sciences, Inc. Foster City, CA 94404. Revised: Sep 2013

See also:
What is the most important information I should know about Allergan France?

Do not receive this medication if you are allergic to Allergan France, probenecid (Benemid), or sulfa drugs, or if you have severe kidney disease.

Allergan France may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Use an effective form of birth control while you are using Allergan France and for at least 1 month after your treatment ends.

Allergan France can affect fertility (ability to have children) in men. If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using Allergan France.

Allergan France must be used together with an oral (taken by mouth) medicine called probenecid (Benemid). Be sure to read the medication guide or patient instructions provided with each of your medications.

There are many other medicines that can interact with Allergan France. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Allergan France has caused certain types of tumors in animals. It is not known if humans would also have an increased risk of tumors. Talk with your doctor about your specific risk.

Use Allergan France as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not inject Allergan France into the eye.
• Allergan France is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Allergan France at home, carefully follow the injection procedures taught to you by your health care provider.
• If Allergan France contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• Continue using Allergan France for the full course of treatment even if you feel better in a few days.
• It is important to take the full course of probenecid prescribed by your doctor in order to help decrease the risk of kidney problems.
• If you miss a dose of Allergan France, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Allergan France.

Use: Labeled Indications

Cytomegalovirus retinitis: Treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.

Limitations of use: Safety and efficacy have not been established for treatment of other CMV infections (eg, pneumonitis, gastroenteritis), congenital or neonatal CMV disease, or CMV disease in non-HIV infected individuals.

Off Label Uses

Herpes simplex virus (HSV) infection, acyclovir-resistant:

Intravenous Allergan France:

Data from case reports in immunocompromised patients (stem cell transplant recipients) suggest that intravenous Allergan France may be effective for acyclovir-resistant HSV type 1 mucosal infections.

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, topical Allergan France 1 % gel might be effective as an alternative agent for the treatment of acyclovir-resistant HSV infections, although limited evidence is available and more studies are needed.

See also:
What other drugs will affect Allergan France?

Probenecid : Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (e.g., acetaminophen, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicylic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine). Concomitant medications should be carefully assessed. Zidovudine should either be temporarily discontinued or decreased by 50% when coadministered with probenecid on the day of Allergan France infusion.

Nephrotoxic agents : Concomitant administration of Allergan France and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and non-steroidal anti-inflammatory agents] is contraindicated. Such agents must be discontinued at least seven days prior to starting therapy with Allergan France.

See also:
What are the possible side effects of Allergan France?

Applies to Allergan France: intravenous solution

As well as its needed effects, Allergan France (the active ingredient contained in Allergan France) may cause unwanted side effects that require medical attention.

Medicines like Allergan France can sometimes cause serious side effects such as blood problems and kidney problems; these are described below. Allergan France has also been found to cause cancer in animals, and there is a chance it could cause cancer in humans as well. Discuss these possible side effects with your doctor.

Major Side Effects

If any of the following side effects occur while taking Allergan France, check with your doctor immediately:

More common:

• Fever, chills, or sore throat

Severity: Moderate

If any of the following side effects occur while taking Allergan France, check with your doctor or nurse as soon as possible:

More common:

• Decreased urination
• increased thirst and urination

• Decreased vision or any change in vision

Minor Side Effects

Some Allergan France side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Diarrhea
• headache
• loss of appetite
• nausea
• vomiting

• Generalized weakness
• loss of strength