XEMBIFY® (immune globulin subcutaneous, human – klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.[1-4]

For subcutaneous infusion only.

Before switching to XEMBIFY, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.

2.1 Dose

Individualize the dose based on the patient’s pharmacokinetic and clinical response.

Measure the patient’s serum IgG trough level as early as 5 weeks after initiating XEMBIFY treatment to determine if a dose adjustment is needed.

Monitor the patient’s IgG trough level every 2 to 3 months to determine subsequent dose adjustments and dosing intervals as needed (Table 1).

Doses divided over the course of a week or once weekly achieve similar exposure when administered regularly at steady-state.

For frequent dosing (2-7 times per week), divide the calculated weekly dose by the desired number of times per week.

For dose adjustments, calculate the difference (in mg/dL) of the patient’s serum IgG trough level from the target IgG trough level, then find this difference in Table 1 (below). Locate the corresponding amount (in mL) by which to increase or decrease the weekly dose based on the patient’s body weight. For example, if a patient with a body weight of 70 kg has an actual IgG trough level of 900 mg/dL and the target level is 1,000 mg/dL, this results in a difference of 100 mg/dL. Therefore, increase the weekly dose of subcutaneous dose by 5 mL.

The patient’s clinical response should be the primary consideration in dose adjustment. If a patient on XEMBIFY does not maintain an adequate clinical response or a serum IgG trough level equivalent to that of a previous treatment, adjust the dose accordingly.

Table 1: Adjustment (±mL) of the Weekly Subcutaneous Dose Based on the Difference (±mg/dL) From the Target Serum IgG Trough Level

* Dose adjustment in mL is based on the slope of the serum IgG trough level response to subcutaneous administration of XEMBIFY dose increments (about 6.6 mg/dL per increment of 1 mg/kg per week).
Difference From Target IgG Trough Level (mg/dL)	Body Weight (kg)
	10	15	20	30	40	50	60	70	80	90	100	110	120
	Dose Adjustment (mL per Week)*
50	0	1	1	1	2	2	2	3	3	3	4	4	5
100	1	1	2	2	3	4	5	5	6	7	8	8	9
150	1	2	2	3	5	6	7	8	9	10	11	13	14
200	2	2	3	5	6	8	9	11	12	14	15	17	18
250	2	3	4	6	8	9	11	13	15	17	19	21	23
300	2	3	5	7	9	11	14	16	18	20	23	25	27
350	3	4	5	8	11	13	16	19	21	24	27	29	32
400	3	5	6	9	12	15	18	21	24	27	30	33	36
450	3	5	7	10	14	17	20	24	27	31	34	38	41
500	4	6	8	11	15	19	23	27	30	34	38	42	45

Switching to XEMBIFY from IVIG

Begin treatment with XEMBIFY one week after the patient’s last IVIG infusion. Calculate the initial weekly dose of XEMBIFY. Divide the previous monthly (or every 3 weeks) IVIG dose in grams by the number of weeks between IVIG infusions, then multiply this dose by the dose adjustment factor of 1.37.

To convert the XEMBIFY dose (in grams) to milliliters (mL), multiply the calculated Initial SC dose (in grams) by 5.

Provided the total weekly dose is maintained, any dosing interval from daily up to weekly will achieve similar systemic IgG exposure when administered regularly at steady-state.

Switching to XEMBIFY from subcutaneous immune globulin (IGSC)

Administer the same weekly dose of XEMBIFY (in grams) as the weekly dose of prior IGSC treatment (in grams).

2.3 Administration

For subcutaneous infusion only.

Prior to use, allow the solution to reach ambient room temperature.
Do not shake.
Follow the steps below and use aseptic technique to administer XEMBIFY.

1. Inspect the vials: inspect for clarity, color, and expiration date (s).

2. Prepare for infusion:

          Gather supplies: XEMBIFY vial(s), ancillary supplies, sharps container, patient’s
          treatment diary/logbook, and the infusion pump.

          Prepare a clean work area.

          Wash hands.

3. Remove the protective cap from the vial to expose the central portion of the stopper. 

          If the packaging shows any sign of tampering, do not use the product and notify
          Grifols Therapeutics LLC immediately [1-800-520-2807].

4. Wipe the stopper with alcohol and allow to dry.

5. Using a sterile syringe and needle, prepare to withdraw XEMBIFY by first injecting air into the vial that is equivalent to the amount of XEMBIFY to be withdrawn. Then withdraw the desired volume of XEMBIFY. If multiple vials are required to achieve the desired dose, repeat this step. (Figure 1) 6. Use XEMBIFY as soon as practicable, within 2 hours to avoid the potential formation of particles caused by siliconized syringes.
7. Follow the manufacturer’s instructions for preparing the pump and administration tubing. Be sure to prime the administration tubing to ensure that no air is left in the tubing or needle by filling the tubing/needle with XEMBIFY.
8. Select the number and location of injection sites. Rotate sites for each administration. (Figure 2) Infuse XEMBIFY in the abdomen, thigh, upper arm, sides, back and/or lateral hip. Avoid bony areas, scars, areas of inflammation, superficial infection or blood vessels.
9. Cleanse the injection site(s) with antiseptic solution using a circular motion working from the center of the site and moving to the outside. Sites should be clean, dry, and at least 2 inches (5cm) apart. (Figure 3)
10. Grasp the skin between 2 fingers (pinch at least one inch (2.5cm) of skin) and insert the needle at a 90-degree angle into the subcutaneous tissue. (Figure 4)
11. After inserting each needle, make sure that a blood vessel has not been accidentally entered. Attach a sterile syringe to the end of the primed administration tubing, pull back on the plunger, and if you see blood, remove and discard the needle and administration tubing. (Figure 5)

12. Repeat priming and needle insertion steps using a new needle, administration tubing
      and a new infusion site. Secure the needle in place by applying sterile gauze or
      transparent dressing over the site.

13. Infuse XEMBIFY at a maximum rate of 25 mL per hour per infusion site using up to
      6 infusion sites (most patients used 4 infusion sites). Ensure that the infusion sites are
      at least 2 inches (5 cm) apart for patients of all ages. The number of infusion sites is
      at healthcare provider discretion. Children will require less total volume for a specific
      XEMBIFY dose (mg/kg body weight) than adults. The healthcare provider may
      choose a smaller volume/site for children and/or fewer infusion sites to achieve the
      target total dose, depending on the needs of the child. The total dose volume of
      XEMBIFY is divided by the desired volume (mL/site) to obtain number of infusion
      sites to be used.

Volume to Be Infused SC	Rate	Number of Sites (most frequent is 4)	Site Distance Apart
25 mL per site	≤ 25 mL/hr/infusion site	≤ 6	≥ 2 inches (5 cm)

       Record information about the infusion (e.g., lot number, expiration date, dose, date,
       time, infusion site location(s), side effects) in a patient treatment record or infusion 
       log.

14.  Discard the needle(s) and infusion line(s) in an appropriate container. Follow the
       manufacturer’s instructions for storage of the infusion pump.

15.  Discard partially used vial(s).

XEMBIFY is a protein solution containing 20% IgG (200 mg/mL; 0.2 g/mL) for subcutaneous infusion.

XEMBIFY is contraindicated in:

Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.

IgA deficient patients with antibodies against IgA and history of hypersensitivity to human immune globulin treatment.

The most common adverse reactions in ≥ 5% of subjects in the clinical trial were local adverse reactions including infusion site erythema (redness), infusion site pain, infusion site swelling (puffiness), infusion site bruising, infusion site nodule, infusion site pruritus (itching), infusion site induration (firmness), infusion site scab, infusion site edema, and systemic reactions including cough and diarrhea.

XEMBIFY, immune globulin subcutaneous, human-klhw, is a 20% ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for subcutaneous administration. The purity is ≥ 98% IgG with a sub-class distribution similar to that found in normal serum.

XEMBIFY consists of 18% to 22% protein in 0.16 M to 0.26 M glycine and 10 to 40 mcg/mL polysorbate 80 at a pH of 4.1 to 4.8.  The solution is clear to slightly opalescent, and colorless or pale yellow.  The osmolality range is 280 to 404 mOsmol/kg. XEMBIFY contains no preservative and is not made with natural rubber latex.

XEMBIFY is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. XEMBIFY is incubated in the final container (at the low pH of 4.1 to 4.8).

The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV-2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g. herpes viruses); West Nile Virus (WNV) as a relevant virus; Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.

Overall virus clearance capacity was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key parameters.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD), and Creutzfeldt-Jakob disease (CJD) agents.

Several of the individual production steps of the manufacturing process have been shown to decrease TSE infectivity of an experimental model agent. TSE reduction steps include depth filtrations (a total of ≥ 6.6 log10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.

Study 1 was a prospective, open-label single-arm, multi-center clinical trial designed to evaluate pharmacokinetics and safety of XEMBIFY as compared to GAMUNEX-C. Efficacy was based on annualized serious bacterial infection (SBI) rate during the 6 months on XEMBIFY. The GAMUNEX-C run-in phase prior to XEMBIFY (subcutaneous phase) lasted 3 or 4 months to achieve steady state prior to pharmacokinetic profiling. The definition of SBI was either bacteremia/sepsis, bacterial meningitis, bacterial pneumonia, osteomyelitis/septic arthritis, or visceral abscess.

This clinical trial determined the safety and pharmacokinetics of XEMBIFY in 53 adult and pediatric subjects with PI (9.4% Hispanic or Latino; 90.6% White, 3.8% Black or African American, 5.7% American Indian or Alaskan Native). During the run-in and IV GAMUNEX-C phases 4 subjects discontinued (1 lost to follow-up, 2 withdrawal by subject, 1 adverse event). XEMBIFY was administered to a total of 49 subjects (14 children aged 2 to ≤ 16 years and 35 adults) with a mean ± SD dose of 179 ± 45 mg/kg/week for a median treatment duration of 24 weeks and mean ± SD of 21.6 ± 6.5 weeks. The median dose was 171 mg/kg/week and the range of doses was 71 mg/kg/week to 276 mg/kg/week. The total exposure of XEMBIFY was 20.28 subject-years and 1053 infusions.

Study 2 is an ongoing study in which XEMBIFY is being administered for 1 year and is being conducted in the European Union and Australia. A total of 61 subjects including 29 children were enrolled. The interim safety data in adult and pediatric study subjects appear consistent with the safety results of the clinical trial in Study 1.

The rate of serious bacterial infections (SBIs) which was an exploratory endpoint in Study 1, was 0.05 events per subject-year (1 event in 20 subject-years) (upper 99% confidence limit: 0.11) during XEMBIFY treatment. This annual rate was lower than 1.0 SBI/subject-year, the threshold specified as effective.

The summary of infections and associated events for subjects during subcutaneous treatment with XEMBIFY is summarized in Table 6.

1. Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med 1991;325(2):110-7.
2. Cunningham-Rundles C, Bodian C. Common variable immunodeficiency: clinical and immunological features of 248 patients. Clin Immunol 1999;92(1):34-48.
3. Pruzanski W, Sussman G, Dorian W, et al. Relationship of the dose of intravenous gammaglobulin to the prevention of infections in adults with common variable immunodeficiency. Inflammation 1996;20(4):353-9.
4. Stephan JL, Vlekova V, Le Deist F, et al. Severe combined immunodeficiency: a retrospective single-center study of clinical presentation and outcome in 117 patients. J Pediatr 1993;123(4):564-72.
5. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;44:223-6.
6. Woodruff RK, Grigg AP, Firkin FC, et al. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986;2:217-8.
7. Wolberg AS, Kon RH, Monroe DM, et al. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000;65:30-4.
8. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997;8(11):1788-94.
9. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003;17:241-51.
10. Copelan EA, Strohm PL, Kennedy MS, et al. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26:410-2.
11. Thomas MJ, Misbah SA, Chapel HM, et al. Hemolysis after high-dose intravenous Ig. Blood 1993;15:3789.
12. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle & Nerve 1997;20:1142-5.
13. Kessary-Shoham H, Levy Y, Shoenfeld Y, et al. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmun 1999;13:129-35.
14. Kahwaji J, Barker E, Pepkowitz S, et al. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol 2009;4:1993-7.
15. Daw Z, Padmore R, Neurath D, et al. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: A case series analysis. Transfusion 2008;48:1598-601.
16. Rizk A, Gorson KC, Kenney L, et al. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001;41:264-8.

XEMBIFY is supplied in 1, 2, 4, and 10 gram single use vials.

Components used in the packaging are not made with natural rubber latex and contains no preservative.

Store XEMBIFY at 2–8°C (36–46°F).

          Note: XEMBIFY may be stored at temperatures not to exceed 25°C (77°F) for up to 6
          months any time prior to the expiration date. Following 25°C (77°F) storage, use the
          product immediately or discard.

Do not freeze.

Do not use solutions that have been frozen.

Do not use after expiration date.

Discard unused portion.

Advise the patient to read the FDA-approved patient labeling (Information for Patients).

Ask about a history of IgA deficiency, and hypersensitivity reactions to immune globulin treatment. [see Warnings and Precautions (5.1)]

Inform patients to immediately report the following signs and symptoms to their healthcare provider: [see Boxed Warning and Warnings and Precautions]

          Hypersensitivity reaction including hives, generalized urticaria, tightness of the chest,
          wheezing, low blood pressure, and anaphylaxis [see Warnings and Precautions (5.1)]

          Symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with
          warmth over the affected area, discoloration of an arm or leg, unexplained shortness of
          breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse,
          numbness or weakness on one side of the body [see Warnings and Precautions (5.2)]

          Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye
          movements, nausea, and vomiting [see Warnings and Precautions (5.3)]

          Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of
          breath [see Warnings and Precautions (5.4)]

          Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine [see
          Warnings and Precautions (5.5)]

          Trouble breathing, chest pain, blue lips or extremities, and fever [see
          Warnings and Precautions (5.6)]

Inform patients/caregivers that because XEMBIFY is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. [see Warnings and Precautions (5.7)]

Inform patients that XEMBIFY can interfere with their immune response to live virus vaccines such as measles, mumps, rubella, and varicella. Inform patients to notify their healthcare provider of this potential interaction when they are receiving vaccinations. [see Drug Interactions (7.2)]

Self-administration

Advise the patient to read the FDA-approved patient labeling (Information for Patients).

If self-administration is deemed appropriate by the healthcare provider, provide clear instructions and training on subcutaneous infusion to the patient/caregiver, and document demonstration of their ability to independently administer subcutaneous infusions.

Ensure the patient/caregiver understands the importance of consistent subcutaneous infusions to maintain appropriate steady IgG levels.

Tell the patient/caregiver to start the infusion promptly after withdrawing XEMBIFY into the syringe. Ensure the patient/caregiver understands that administration should be completed within 2 hours to avoid the potential formation of particles caused by siliconized syringes.

Instruct patient to rotate infusion sites for subsequent infusions.

Instruct the patient/caregiver to keep a treatment diary/log book. This diary/log book should include information about each infusion such as, the time, date, dose, lot number(s), infusion sites, and any reactions.

Inform the patient that mild to moderate local infusion site reactions (e.g., pain, redness and itching) are a common side effect of subcutaneous treatment, but to contact their healthcare provider if a local reaction increases in severity or persists for more than a few days.

Instruct patient to return to the healthcare facility for evaluation at regular intervals so IgG levels can be checked in order to ensure IgG trough levels are adequate.

Manufactured by:



Grifols Therapeutics LLC

Research Triangle Park, NC 27709 USA

U.S. License No. 1871

3056462

XEMBIFY®
(immune globulin subcutaneous, human-klhw) 20% solution

The following summarizes important information about XEMBIFY (zem-ba-fi). Please read this information carefully before using this medicine. This patient information does not take the place of talking with your healthcare provider about your medical condition or your treatment, and it does not include all of the important information about XEMBIFY. If you have any questions after reading this, contact your healthcare provider.

What is XEMBIFY?

XEMBIFY is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. XEMBIFY is used to treat patients with primary immunodeficiency disease (PI).

There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. XEMBIFY is made from human plasma that is donated by healthy people. It contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.

Who should NOT use XEMBIFY?

Do not use XEMBIFY if you have a known history of severe allergic reaction to immune globulin (human) or other blood products. If you have such a history, discuss this with your healthcare provider to determine if XEMBIFY is right for you.

Tell your healthcare provider if you have or ever had:

• a serious reaction to other medicines that contain immune globulin.
• an immunoglobulin A (IgA) deficiency.
• a history of heart or blood vessel disease.
• blood clots or “thick blood”.
• inability to move for some time.

How should I take XEMBIFY?

XEMBIFY is given under the skin (subcutaneously). Most of the time, infusions under the skin are given at home by self-infusion or by infusion with a caregiver’s help. Self-infusion is different from giving yourself a shot.

Instructions for taking XEMBIFY are at the end of this patient information. [see "Instructions for Use"] Only use XEMBIFY by yourself after you have been instructed by your healthcare provider.

What should I tell my healthcare provider before using XEMBIFY?

Tell your healthcare provider if you have had a serious reaction to other medicines that contain immune globulin. Also tell your healthcare provider if you have an immunoglobulin A (IgA) deficiency.

XEMBIFY can make certain types of vaccines (like measles/mumps/rubella or chickenpox) not work as well for you. Before you get a vaccine, tell the healthcare provider that you are taking XEMBIFY.

Tell your healthcare provider if you are pregnant or plan to become pregnant, or if you are nursing.

What are possible or reasonably likely side effects of XEMBIFY?

The most common side effects with XEMBIFY are:
      Infusion site reactions, including but not limited to
            infusion site erythema (redness) 
            infusion site pain
            infusion site swelling (puffiness)
            infusion site bruising
            infusion site nodule
            infusion site pruritus (itching)
            infusion site induration (firmness)
            infusion site scab
            infusion site edema
      Cough
      Diarrhea

If any of the following problems occur after starting treatment with XEMBIFY, stop the infusion immediately and contact your healthcare provider or call emergency services. These could be signs of a serious problem.

      Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness.
      These could be signs of a serious allergic reaction.

      Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light.
      These could be signs of irritation of the lining around your brain.

      Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.

      Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.

      Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem.

      Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.

      Severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea and vomiting.
      These could be signs of a type of brain inflammation called aseptic meningitis.

      Fever over 100°F (37.8oC). This could be a sign of an infection.

Tell your healthcare provider about any side effects that concern you. You can ask your healthcare provider to give you the full prescribing information available to healthcare providers. You are encouraged to report side effects to Grifols Therapeutics LLC [1-800-520-2807].

How do I store XEMBIFY?

XEMBIFY comes in single use vials.

• Keep XEMBIFY refrigerated. Do not freeze.
• If needed, you can store XEMBIFY at room temperature for up to 6 months, but you must use it within that time or you must throw it away.
• Do not return XEMBIFY to the refrigerator if it was warmed to room temperature.
• Check the expiration date on the carton and vial label.
• Do not use XEMBIFY after the expiration date.

What else should I know about XEMBIFY?

Do not use XEMBIFY for a medical condition for which it was not prescribed.  Do not share XEMBIFY with other people, even if they have the same diagnosis and symptoms that you have.

Infuse XEMBIFY only after you have been trained by your healthcare provider. Below are step-by-step instructions to help you remember how to use XEMBIFY. Ask your healthcare provider about any instructions you do not understand.

Before Using XEMBIFY

Prior to use, allow the solution to come to room temperature (68-77°F or 20-25°C). This can take 60 minutes or longer.

Do not apply heat or place in the microwave.

Step 1: Assemble supplies

Gather the XEMBIFY vial(s), ancillary supplies, sharps container, patient’s treatment diary/logbook, and the infusion pump.

Step 2: Clean surface

Set up your infusion area on a clean, flat, non-porous surface, such as a kitchen counter.

Avoid using porous surfaces such as wood. Clean the surface with an alcohol wipe using a circular motion from the center outward.

Step 3: Wash hands

Wash and dry your hands thoroughly before using XEMBIFY.

Your healthcare provider may recommend that you use antibacterial soap or that you wear gloves.

Step 4: Check vials

The liquid in the vial should be clear to slightly opalescent, and colorless or pale yellow.

Do not use the vial if:

• the solution is cloudy or discolored. The solution should be clear to slightly opalescent, and colorless or pale yellow.
• the protective cap is missing, or there is any evidence of tampering. Tell your healthcare provider immediately.
• the expiration date has passed.

Step 5: Remove the protective cap

Remove the protective cap from the vial to expose the middle of the stopper.

Wipe the stopper with alcohol and allow to dry.

Step 6: Transfer XEMBIFY from vial(s) to syringe

Do not allow your fingers or other objects to touch the inner stem of the plunger, the syringe tip, or other areas that can touch the XEMBIFY solution. Make sure needles are capped until used and that needles and syringes stay on the clean area created in Step 2. This is called “aseptic technique” to prevent germs from getting into the XEMBIFY.

Using aseptic technique, attach each needle to the syringe tip.

Step 7: Prepare the syringe and draw XEMBIFY solution into syringe

Remove cap from needle.

Pull the syringe plunger back to the level matching the amount of XEMBIFY to be withdrawn from the vial.

Place the XEMBIFY vial on a clean flat surface and insert the needle into the center of the vial stopper.

Inject air into the vial. The amount of air should match the amount of XEMBIFY to be withdrawn.

Turn the vial upside down and withdraw the correct amount of XEMBIFY. If multiple vials are required to get the correct dose, repeat Step 4.

Step 8: Fill the pump reservoir and prepare the infusion pump

Follow the pump manufacturer’s instructions for filling the pump reservoir and preparing the infusion pump, administration tubing and Y-site connection tubing, if needed.

Prime the administration tubing with XEMBIFY to take out any air left in the tubing or needle. To prime, hold the syringe in one hand and the administration tubing’s capped needle in the other. Gently squeeze on the plunger until you see a drop of XEMBIFY come out of the needle.

Step 9: Select the number and location of infusion sites

Select one or more infusion sites as directed by your healthcare provider. The number and location of injection sites depends on the volume of the total dose.

Avoid: bony areas, visible blood vessels, scars, and any areas of inflammation (irritation) or infection.

Rotate sites between future infusions.

Step 10: Prepare the infusion site

Wipe the infusion site(s) with a sterile alcohol wipe beginning at the center of each infusion site and moving outward in circular motion. Allow the infusion site(s) to dry (at least 30 seconds).

Before infusion, sites should be clean, dry, and at least 2 inches (5cm) apart.

Step 11: Insert the needle

Grasp the skin between two fingers (pinch at least 1 inch (2.5 cm) of skin) and insert the needle at a 90-degree angle into the tissue underneath the skin or subcutaneous tissue.

Step 12: Make sure the needle is not in a blood vessel

After inserting each needle into tissue (and before your infusion), make sure that a blood vessel has not been accidentally entered. To do this, attach a sterile syringe to the end of the primed administration tubing. Pull back on the syringe plunger and watch for any blood flowing back into administration tubing.

If you see any blood, remove and discard the needle and administration tubing.

Repeat priming and needle insertion steps using a new needle, administration tubing and a new infusion site.

Secure the needle in place by applying sterile gauze or transparent dressing over the site.

Step 13: Repeat for other sites, as needed

Step 14: Infuse XEMBIFY

Infuse XEMBIFY as soon as possible after it is prepared.

Follow the pump manufacturer’s instructions for filling the tubing and using the infusion pump.

Step 15: After infusion

Follow manufacturer’s instructions to turn off pump.

Undo and discard any dressing or tape.

Gently remove the inserted needle(s) or catheter(s).

Discard any unused solution in an appropriate waste container as instructed.

Discard any used administration equipment in an appropriate waste container.

Store your supplies in a safe place.

Follow manufacturer’s instructions to care for the infusion pump.

Step 16: Record each infusion

Remove the peel-off label with the product lot number from the XEMBIFY vial and use this to complete the patient record. Include information about each infusion such as: the time, date, dose, lot number(s), infusion sites, and any reactions.

Remember to bring your journal with you when you visit your healthcare provider. Your healthcare provider may ask to see your treatment diary/logbook.

Tell your healthcare provider about any problems you have during your infusions. Call your healthcare provider for medical advice about side effects. You can also report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:



Grifols Therapeutics LLC

Research Triangle Park, NC 27709 USA

U.S. License No. 1871

3056462

Revised 8/2020

NDC 13533-810-50

10 g / 50 mL

Immune Globulin
Subcutaneous,
Human - klhw, 20%

Xembify®

Solution for Subcutaneous Administration

Rx only

GRIFOLS

Contents:

One vial of Xembify®  

No preservative

Sterile, Non-pyrogenic

Xembify® may be stored at 2–8°C (36–
46°F), AND product may be stored at
temperatures not to exceed 25°C (77°F)
for up to 6 months anytime prior to the
expiration date, after which the product
must be immediately used or discarded.
Do not freeze.

Date removed from refrigeration:

GRIFOLS

Refer to package insert for dosage
and administration.

Single Use Vial
Do not use if turbid.
Discard unused portion. Do not store
after entry into vial.

Each milliliter (mL) contains approxi-
mately 200 mg of protein, not less
than 98% of which is gamma
globulin, and approximately 15 mg
glycine and 25 mcg polysorbate 80.

Do not use the product if it shows
any signs of tampering and notify
Grifols Therapeutics LLC immediately.

Grifols Therapeutics LLC
Research Triangle Park,
NC 27709 USA
U.S. License No. 1871

GRIFOLS

GRIFOLS

GTIN (01)00313533810504
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN   XXXXXXXXXXXXXXXX

Immune Globulin
Subcutaneous,
Human – klhw, 20%

Xembify®

Carton: 3057222

NDC 13533-810-51

10 g / 50 mL

Immune Globulin
Subcutaneous,
Human - klhw, 20%

Xembify®

Solution for
subcutaneous administration

Rx Only

GRIFOLS

Refer to package insert for dosage and administration and compatibility
with other solutions.
Xembify® may be stored at 2–8°C (36–46°F), AND product may be stored at
temperatures not to exceed 25°C (77°F) for up to 6 months anytime prior to
the expiration date, after which the product must be immediately used or
discarded.
Single Use Vial, Discard unused portion
Do not use if turbid.
Grifols Therapeutics LLC
Research Triangle Park, NC 27709 USA
U.S. License No. 1871

Xembify® 10 g Protein in 50 mL PULL

Lot

3057120

Lot

Exp.