Glycophos

IMPORTANT PRESCRIBING INFORMATION

October 30, 2017

Subject: Temporary importation of Glycophos to address drug shortage issues

Dear Healthcare Professional,

Due to the critical shortage of phosphate injection in the U.S. market, Fresenius Kabi USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and Drug Administration (FDA) to provide an alternative treatment option during this critical shortage period. Fresenius Kabi USA has initiated temporary importation of a Glycophos^TM 20 mL Injection Single Dose Plastic Vial into the U.S. market. This product is marketed in Europe, and is manufactured in the Fresenius Kabi Norway plant.

At this time, no other entity except Fresenius Kabi USA is authorized by the FDA to import or distribute Glycophos^TM 20 mL Injection Single Dose Plastic Vial in the U.S. FDA has not approved Fresenius Kabi's Glycophos^TM in the United States.

Effective immediately, and during this temporary period, Fresenius Kabi USA will offer the following presentation of phosphate injection:

The vial and carton labels will display the text used when marketing the product in English speaking countries.

It is important to note that there are some key differences in the formulation and labeling
between the current U.S. marketed phosphate injection products and Glycophos that you need to be aware of:

market
Refer to the Glycophos package insert for full prescribing information

This communication and product information is available on the Fresenius Kabi USA web site products.fresenius-kabi.us/product-323.html as well as on the FDA Drug Shortage web site. www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.

To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA Vigilance or Medical Affairs at 1-800-551-7176, Monday – Friday, between the hours of 8 a.m. and 5 p.m. (CST), or e-mail adverse.events.USA@fresenius-kabi.com or productcomplaint.USA@fresenius-kabi.com. 

Fresenius Kabi USA CONTACT  NUMBERS: Please use the following contact numbers as appropriate:

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

Sincerely,
Melanie Power-Burns
Vice President, Quality and Compliance


Key Differences between U.S. Marketed Phosphate Injection Products and Glycophos

1. Data on file.

Comparison Table of U.S. Phosphate Injection Products to Glycophos

Phosphate Label Product Comparison Table
comparison table

1.     QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of Glycophos contains

Active ingredient                                               Quantity            

Sodium glycerophosphate pentahydrate            306.1 mg*

*Corresponds to 216 mg sodium glycerophosphate           

The active ingredient in 1 ml of Glycophos correspond to

Phosphate        1 mmol

Sodium            2 mmol

For excipients, see 5.1

PRODUCT PROPERTIES

•    Osmolality: 2760 mosm/kg water

•    pH: 7.4

2.     PHARMACEUTICAL FORM

Concentrate for solution for infusion.

3.     CLINICAL PARTICULARS

3.1   Therapeutic indications

Glycophos is indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirements of phosphate.

3.2    Posology and method of administration

Glycophos must not be given undiluted.

Adults:

The recommended dosage is individual. The recommended daily dosage of phosphate during intravenous nutrition would normally be 10-20 mmol. This can be met by using 10-20 ml of Glycophos added to the infusion solution or to the admixture for which compatibility has been proved.

Infants:

The recommended dosage is individual. The recommended dose for infants and neonates is 1.0-1.5 mmol/Kg body weight/day.

3.3    Contra-indications

Glycophos should not be given to patients in a state of dehydration or with hypernatraemia, hyperphosphataemia, severe renal insufficiency or shock.

3.4    Special warnings and special precautions for use

Glycophos should be used with caution in patients with impaired renal function. The phosphate status of all patients should be monitored regularly.

Glycophos must not be given undiluted.

3.5    Interaction with other medicaments and other forms of interaction

No interactions with other drugs have been observed, but a moderate fall in serum phosphate can be seen during carbohydrate infusions.

3.6    Pregnancy and lactation

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Glycophos. However, the requirements of phosphate in a pregnant woman are slightly increased compared to non-pregnant women.

No adverse events are to be expected when Glycophos is administered during pregnancy.

3.7    Effects on ability to drive and use machines

No effects on the ability to drive and use machines are to be expected.

3.8    Undesirable effects

No adverse effects related to glycerophosphate have been reported.

3.9    Overdose

No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. See also 3.3 "Contra-indications".

4.      PHARMACOLOGICAL PROPERTIES

4.1    Pharmacodynamic properties

Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely.

4.2    Pharmacokinetic properties

To become available it is necessary for the phosphate group to be hydrolysed from the glycerophosphate molecule. The hydrolysis occurs maximally at a plasma concentration of >0.7 mmol/l. Assuming that all hydrolysis of glycerophosphate takes place in plasma, about 12-15 mmol of sodium glycerophosphate will be hydrolysed each day in individuals with normal serum alkaline phosphatase.

No pharmacokinetical data is available for infants, however with the recommended dosage hyperphosphataemia is unlikely.

4.3    Preclinical safety data

Preclinical safety studies on Glycophos demonstrated good tolerance.

5.      PHARMACEUTICAL PARTICULARS

5.1    List of excipients

Hydrochloric acid

Water for Injections                       

5.2    Incompatibilities

Glycophos may only be added to or mixed with other medicinal products for which compatibility has been documented. See 5.6.

5.3    Shelf life

3 years

5.4    Special precautions for storage

Do not store above 25°C. Do not freeze.

5.5    Nature and contents of container

Polypropylene vial.           

Pack size: 10 x 20 ml

5.6    Instructions for use/handling

Glycophos must not be given undiluted.

Compatibility

Additions should be made aseptically.

Up to 120 ml of Glycophos and 48 mmol of calcium (as CaCl₂) can be added to 1000 ml Vamin Glucose, Vamin 9 Electrolyte Free, Vamin 14, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free and Vaminolact.

Up to 10 ml of Glycophos and 10 mmol of calcium (as CaCl₂) can be added to 1000 ml Glucose 50 mg/ml.

Up to 20 ml of Glycophos and 20 mmol of calcium (as CaCl₂) can be added to 1000 ml Glucose 200 mg/ml.

Up to 60 mmol of Glycophos and 24 mmol of calcium (as CaCl₂) can be added to 1000 ml Glucose 500 mg/ml.

Infusion time

The infusion time should not be less than 8 hours.

Stability

When additions are made to an infusion solution, the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. The left over contents of opened bottles/vials/ampoules should be discarded and not kept for later use.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Glycophos 20 mL Vial Label

20 ml

Glycophos™

Sterile concentrate

 vial-lyv1963

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Glycophos 20 mL Vial Carton Panel

10 vials of 20 ml

Glycophos™

Sterile concentrate

carton-lyv1963