2.1 Basic Dosing Information

DELFLEX® is intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration.

The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for the treatment of the individual patient.

Utilize the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.

Do not store solutions containing additives.

2.2 Administration Instructions

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not heat in a microwave oven.

Get Ready

1. Clean work surface and gather supplies:
   • Masks (enough for everyone in the room).
   • Warmed DELFLEX peritoneal dialysis solution bag with attached stay•safe exchange set.
   • stay•safe organizer, a stand-alone item provided separately.
   • Povidone iodine prefilled stay•safe cap, a stand-alone item provided separately.
   • IV Pole (optional).
   • Prescribed medication(s), if ordered by your healthcare provider.
2. After removing the overwrap, check your DELFLEX solution bag(s) for strength, clarity, amount, leaks, and expiration date. Do not use DELFLEX solution if leaks are found, the solution bag is damaged, the solution is cloudy or discolored, and/or the product is expired. Color may vary from clear to slightly yellow but does not affect efficacy and may be used.
3. Prepare supplies:
   1. Retrieve stay•safe catheter extension set and ensure clamp is closed.
   2. Tear the overwrap from the slit edge down the length of the inner bag to open.
   3. Wipe away any moisture from the solution bags. Some opacity may be observed in the plastic of the bag and/ or tubing and is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
   4. Visually check that the solution bag tubing is free from kinks. If kinks are present, straighten tubing to allow the solution to flow freely.

      Note: Retain DELFLEX peritoneal dialysis bag sample for manufacturer evaluation and notify your healthcare provider if any of the above defects are found.

   5. Put on mask. Wash your hands per facility protocol.
   6. Position the stay•safe organizer at the edge of your clean work surface or with the stay•safe holder on the IV pole.
4. Remove color-coded cover:
   1. Turn the blue dial as directed by the arrow in the color—coded cover.

   2. Remove the colored—coded cover from the stay•safe DISC. The blue dial will be in Position 1 ( ) DRAIN.

   
5. Prepare organizer and solution bag:
   1. Place the stay•safe DISC and tubing into the organizer and tubing channels on the organizer.
      
   2. If you will be adding medication(s):
      1. Clean hands (as per facility's protocol).
      2. Clean the medication port as instructed by your healthcare provider.
      3. Add the medicine(s).
      4. Turn the bag upside down several times to mix the medicine(s).
   3. Hang the DELFLEX peritoneal dialysis solution bag on the IV pole and place the drain bag with the clear side up on the floor.
   4. Break cone of the administration port.
6. Remove new stay•safe cap from its package and place stay•safe cap into the left notch of the organizer.
   
7. Place stay•safe catheter extension set into organizer.
   1. Clean hands (as per facility's protocol).
   2. Place stay•safe catheter extension set into the right notch of the organizer.
   3. Ensure clamp of stay•safe catheter extension set is closed.
      
8. Remove protective cap from stay•safe DISC and set aside.
   
9. Connect stay•safe catheter extension set to the stay•safe DISC.
   1. Unscrew stay•safe catheter extension set from its cap.
   2. Immediately connect the stay•safe catheter extension set to the stay•safe DISC.
   3. Open the white clamp of stay•safe catheter extension set and start DRAIN.
   4. Place discarded protective cap from stay•safe DISC onto the used stay•safe cap in the stay•safe organizer and discard.
      
10. When DRAIN is complete:

    1. Turn blue dial to Position 2( ), FLUSH for about 5 seconds.

    2. Make sure the line between solution bag and stay•safe DISC is fully primed.
       
11. When FLUSH is complete:

    1. Turn blue dial to Position 3( ), FILL to begin the fill of solution to your abdomen. Flow rate can be adjusted from slow( ) to moderate ( ) to fast ( ).

       
12. When FILL is complete:

    1. Turn blue dial as far as possible in Position 4 ( ), PIN/CLOSE until you feel and/or hear a “click”.

    2. The stay•safe PIN located in the stay•safe DISC will automatically be released into the end of the stay•safe catheter extension set.
       
13. When PIN/CLOSE is complete:
    1. Close the clamp of the stay•safe catheter extension set.
    2. Using aseptic technique, mask then wash hands as instructed by your healcare provider.
    3. Unscrew protective cover from the new stay•safe cap and set aside.
       
14. Disconnect from stay•safe DISC:
    1. Unscrew the stay•safe catheter extension set from the stay•safe DISC.
    2. Immediately attach the stay•safe catheter extension set with a PIN to the new stay•safe cap.
    3. Remove capped catheter extension set from organizer and secure to your abdomen.
       
15. Complete treatment:
    1. Place protective cover from the new stay•safe cap on the stay•safe DISC connector to prevent drips.
    2. Weigh drain bag (as per facility's protocol).
    3. Record exchange results on treatment log.
    4. If an effluent sample is required:
       1. Use aseptic technique and facility protocols throughout collection.
       2. Scrub the drain bag's sample port hub with friction and an Isopropyl Alcohol 70% swab/prep pad for 15 seconds, and allow to dry for 30 seconds more.
       3. Withdraw the effluent sample directly from the sample port hub with a needle and syringe.
    5. Discard the used tubing and solution (as per facility's protocol).
    6. Throw away the fluid and used exchange set as instructed by your healthcare provider. In case of cloudiness, save the fluid and the used exchange set and immediately contact your healthcare provider.

2.3 Compatible Medications

Compatible medications can be added via the medication port [ see Dosage and Administration ( 2.2) ]. The following medications have demonstrated stability with DELFLEX solutions: cefazolin, ceftazidime, gentamicin, and vancomycin [ see Clinical Pharmacology ( 12.3) ].

5.1 Electrolyte, Fluid and Nutrition Imbalances

Peritoneal dialysis may affect a patient's protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically and take appropriate clinical action.

Potassium is omitted from DELFLEX solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.

To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.

Significant loss of protein, amino acids and water-soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

5.2 Peritonitis and Encapsulating Peritoneal Sclerosis

Infectious and aseptic peritonitis has been associated with peritoneal dialysis therapy. Following DELFLEX use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy.

Encapsulating peritoneal sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy.

5.3 Lactic Acidosis

Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute kidney failure, inborn errors of metabolism, treatment with drugs such as nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs)] for lactic acidosis before the start of treatment and during treatment with DELFLEX.

Solutions containing the lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.

5.4 Over Infusion

Over infusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat over infusion.

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

12.1 Mechanism of Action

DELFLEX peritoneal dialysis solutions are hypertonic peritoneal dialysis solutions containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DELFLEX solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DELFLEX solutions contain electrolytes to facilitate the correction of acid- base and electrolyte abnormalities. DELFLEX solutions contain a buffer, lactate, to help normalize acid-base abnormalities.

12.3 Pharmacokinetics

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies with DELFLEX peritoneal dialysis solutions have not been performed to evaluate the carcinogenic potential, mutagenic potential or effect on fertility.