What is Alprolix?

Alprolix is used to help control and prevent bleeding in people with hemophilia B (congenital Factor IX deficiency). Alprolix is a coagulation Factor IX concentrate that replaces the missing or low levels of Factor IX; this helps control bleeding episodes, manage bleeding in surgery, and can be used regularly to prevent bleeding episodes. Coagulation Factor IX is sometimes written as coagulation Factor 9.

Alprolix is a recombinant Factor product, which means it is developed in a laboratory and is not human plasma derived from donor-sourced plasma.

Hemophilia B is a genetic disorder that causes low levels of a clotting protein called Factor IX, this causes individuals to bleed for a longer time than other people.  External bleeding can be due to dental procedures, minor cuts, or trauma and can also involve internal bleeding into joints and muscles.

Alprolix FDA approval was received on March 28, 2014, for the company Biogen Idec. It is now manufactured for Bioverativ Therapeutics Inc. which is a Sanofi Company.

Alprolix side effects

Common side effects of Alprolix 

Common Alprolix side effects may include nausea, headache, dizziness, altered sense of taste, mild skin rash, or pain, redness, itching, stinging, or other irritation where the medicine was injected.

Serious side effects of Alprolix 

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, tightness in your chest, difficult breathing, fast heartbeats, blue lips, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Alprolix may cause other serious side effects. Call your doctor at once if you have:

• weight gain, swelling in your waist, hands, or lower legs;
• loss of appetite;
• fever or chills;
• continued bleeding after treatment;
• new or worsened bleeding; or
• signs of excessive blood clotting–sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth, and redness in one or both legs.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use Alprolix if you are allergic to Alprolix or any of the other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using Alprolix.

Before using this medicine

Tell your doctor about all of your medical conditions, including if you:

• have been told that you have inhibitors to Factor IX (because Alprolix may not work for you).

Pregnancy

Tell you healthcare provider if you are pregnant or planning to become pregnant. It is not known if Alprolix may harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if Alprolix passes into breast milk or if it can harm your baby.

How should I use Alprolix?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Alprolix is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Alprolix Administration

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Alprolix must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

The mixture should appear clear, yellow, or colorless. Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Gently swirl but do not shake the medicine while mixing or you may ruin the medicine. Use the injection within 3 hours after mixing your dose.

You may need frequent blood tests.

In case of emergency, wear or carry medical identification to let others know you have a bleeding disorder.

Alprolix Dosing information

On-demand treatment and control of bleeding episodes:

Perioperative management:

• Minor surgery: a single infusion to reach FIX level of 50–80 IU/dL may be sufficient. Repeat as needed after 24–48 hours until bleeding stops and healing is achieved.
• Major surgery: initial infusion to reach FIX level of 60–100 IU/dL. Consider a repeat dose after 6–10 hours and then every 24 hours for the first 3 days, then every 48 hours until bleeding stops and healing is achieved.

Routine prophylaxis:

For adults and adolescents ≥12 years of age, start at 50 IU/kg once weekly or 100 IU/kg once every 10 days.
For children <12 years of age, start at 60 IU/kg once weekly.
Adjust dosing regimen based on individual response. More frequent or higher doses may be needed in children <12 years of age.

Use: adults and children with hemophilia B for:

• On-demand treatment and control of bleeding episodes,
• Perioperative management of bleeding,
• Routine prophylaxis to reduce the frequency of bleeding episodes.

What other drugs will affect Alprolix?

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.

There are no known drugs interactions with Alprolix.

Storage

Store Alprolix vials at 2°C to 8°C (36°F to 46°F). Do not freeze.

Alprolix vials may also be stored at room temperature up to 30°C (86°F) for a single 6-month period.

If you choose to store Alprolix at room temperature:

• Note on the carton the date on which the product was removed from refrigeration.
• Use the product before the end of this 6-month period or discard it.
• Do not return the product to the refrigerator.

Do not use product or diluent after the expiration date printed on the carton, vial, or syringe.

After Reconstitution:

• Use the reconstituted product as soon as possible; however, you may store the reconstituted product at room temperature up to 30°C (86°F) for up to 3 hours. Protect the reconstituted product from direct sunlight. Discard any product not used within 3 hours after reconstitution.
• Do not use Alprolix if the reconstituted solution is cloudy, contains particles or is not colorless.

What else should I know about Alprolix?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Alprolix for a condition for which it was not prescribed. Do not share it with other people, even if they have the same symptoms that you have.

Alprolix Instructions for Use

Read the Instructions for Use before you start using Alprolix and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you or your caregiver how to reconstitute and administer Alprolix the first time Alprolix is used.

Check the expiration date on the Alprolix kit.

Do not use the product if past the expiration date.

Allow the Alprolix vial and the diluent to come to room temperature.

Do not use external heat sources such as putting the vial and/or diluent in hot water.

Find a clean, flat work surface and collect all the supplies you will need to reconstitute and administer Alprolix.

Wash your hands with soap and water. Aseptic technique (clean and germ free) should be used.

Alprolix Reconstitution

Step 1:  Remove the plastic cap from the Alprolix vial. Wipe the rubber stopper of the vial with an alcohol wipe and allow it to dry.
After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.

Step 2:  Completely remove the backing from the vial adapter package by peeling back the lid.
Do not remove the vial adapter from the package or touch the inside of the vial adapter.

Step 3:  Keep the vial on a flat surface. Hold the vial adapter package with one hand and using the other hand, place the vial adapter over the vial.
The spike should be placed directly above the center of the rubber stopper.
Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted.

Step 4:  Lift the package cover away from the vial adapter and discard the cover.

Step 5: Only use the diluent syringe provided to reconstitute the drug product.
Hold the plunger rod at the circular disk.
Place the tip of the plunger rod into the end of the syringe.
Turn in a clockwise motion until it is securely attached.

Step 6:  With one hand, hold the diluent syringe right under the cap, and with the cap pointing up.
Make sure you are holding the diluent syringe by the ridged part directly under the cap.
Do not use if the cap has been removed or is not securely attached.

Step 7:  With your other hand, grasp the cap and bend it at a 90° angle until it snaps off.
After the cap snaps off, you will see the glass tip of the syringe.
Do not touch the glass tip of the syringe or inside of the cap.

Step 8: Be sure the vial is sitting on a flat surface.
Insert the tip of the syringe into the adapter opening.
Turn the syringe in a clockwise motion until it is securely attached to the adapter.

Step 9: Slowly depress the plunger rod to inject all of the diluent into the vial.
The plunger rod may rise slightly after this process. This is normal.

Step 10:  With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved.
The appearance of the solution should be clear to slightly opalescent and colorless.
Do not shake.
Do not use the reconstituted Alprolix if it contains visible particles or is cloudy.

If you are using more than one vial, stop here and proceed to the Pooling Instructions on the back.

Step 11:  Make sure the plunger rod is completely depressed.
Turn the vial upside-down.
Slowly pull on the plunger rod to draw the solution into the syringe.
Be careful not to pull the plunger rod completely out of the syringe.

Step 12:  Gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter still attached.
Do not touch the syringe tip or the inside of the cap.
Reconstituted Alprolix should be administered as soon as possible. Figure

Alprolix Pooling

Pooling is the process of combining two or more reconstituted vials into a larger syringe (not into the diluent syringe) prior to intravenous administration.

If you are using two or more vials, follow these pooling steps.

Be sure to leave the vial adapter attached to the vial as you will need it for attaching a large luer lock syringe.

Do not detach the diluent syringe or the large luer syringe until you are ready to attach the large luer lock syringe to the next vial (with vial adapter attached).

Step 1:  Remove the diluent syringe from the vial adapter by turning it counterclockwise until it is completely detached.

Step 2:  Attach a separate large luer lock syringe by turning clockwise until it is securely attached.

Step 3:  Slowly pull on the plunger rod to draw the solution into the syringe.
Repeat this pooling procedure with each vial you will be using.
Once you have pooled the required dose, proceed to administration using the large luer lock syringe.

Alprolix Administration (Intravenous Injection)

Alprolix is administered by intravenous infusion after reconstitution of the drug powder with the diluent.

Your healthcare provider should teach you how to infuse Alprolix. Once you have been taught to self-infuse, you can follow these instructions.

Do not administer reconstituted Alprolix if it contains particulate matter, is discolored, or is cloudy.

Step 1: Attach the syringe to the connector end of the infusion set tubing by turning clockwise until it is securely attached.
Do not administer reconstituted Alprolix in the same tubing or container with other medicinal products.

Step 2:  Apply a tourniquet and clean the skin area where you will perform the infusion using an alcohol wipe.

Step 3: Depress the plunger until all air is removed from the syringe and Alprolix has reached the end of the infusion set tubing.
Do not push Alprolix through the needle.

Step 4:  Remove the protective needle cover from the infusion set tubing.
Insert the needle on the infusion set tubing into the vein.
Remove the tourniquet.
Always verify proper needle placement when performing intravenous administration.

Step 5: Slowly depress the plunger on the syringe to administer Alprolix.
Alprolix should be injected intravenously over several minutes.
The rate of administration should be determined by your comfort level.
The small amount of drug product left in the infusion set will not affect treatment.

Step 6: After infusing Alprolix, remove the infusion set and use a sterile gauze to put pressure on the infusion site for several minutes.
Apply an adhesive bandage if necessary.

What is Aldactone?

Aldactone is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Aldactone is used to treat heart failure, high blood pressure (hypertension), or hypokalemia (low potassium levels in the blood).

Aldactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome.

Aldactone is also used to diagnose or treat a condition in which you have too much aldosterone in your body. Aldosterone is a hormone produced by your adrenal glands to help regulate the salt and water balance in your body.

Warnings

You should use Aldactone with caution if you have kidney problems, high levels of potassium in your blood, Addison’s disease, if you are unable to urinate, or if you are also taking eplerenone.

Aldactone has caused tumors in animals but it is not known whether this could occur in people. Do not use this medicine for any condition that has not been checked by your doctor.

Before taking this medicine

You should not use Aldactone if you are allergic to spironolactone, or if you have:

• Addison’s disease (an adrenal gland disorder);
• high levels of potassium in your blood (hyperkalemia);
• if you are unable to urinate; or
• if you are also taking eplerenone.

To make sure Aldactone is safe for you, tell your doctor if you have:

• an electrolyte imbalance (such as low levels of calcium, magnesium, or sodium in your blood);
• kidney disease;
• liver disease; or
• heart disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having congestive heart failure, cirrhosis, or uncontrolled high blood pressure during pregnancy may lead to medical problems in the mother or the baby. Your doctor should decide whether you take Aldactone if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Aldactone?

Take Aldactone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not share this medicine with another person, even if they have the same symptoms you have.

You may take Aldactone with or without food, but take it the same way each time.

You will need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Aldactone.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from heat, light, and moisture.

Dosing information

Usual Adult Dose of Aldactone for Edema:

25 to 200 mg orally per day in single or divided doses

Duration of therapy: When given as the sole diuretic, continue the initial dose for at least 5 days, after which the initial dose may be adjusted to an optimal maintenance dose.

Comments:

-A second diuretic that acts more proximally at the renal tubule may be added if adequate diuresis has not been achieved after 5 days. The dose of this drug should remain unchanged if a second diuretic is added.

Uses:

-Treatment of edematous conditions in patients with congestive heart failure who are only partially responsive to or intolerant of other therapeutic measures or who are taking digitalis when other therapies are considered inappropriate.

-Treatment of edematous conditions in patients with liver cirrhosis accompanied by edema and/or ascites.

-Treatment of edematous conditions in patients with nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Usual Adult Dose of Aldactone for Hypertension:

Initial dose: 50 to 100 mg orally per day in single or divided doses

Duration of therapy: Treatment should be continued for at least 2 weeks to achieve a maximum response. Subsequently, the dose may be adjusted according to patient response.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg orally once a day assuming serum potassium is less than or equal to 5 mEq/L and serum creatinine is less than or equal to 2.5 mg/dL

Maintenance dose:

-Patients tolerant of initial dose: May increase to 50 mg orally once a day as clinically indicated

-Patients intolerant of initial dose: May decrease to 25 mg orally every other day

Use: To increase survival and reduce the need for hospitalization of severe heart failure patients (New York Heart Association [NYHA] class III to IV) when used in addition to standard therapy.

Usual Adult Dose for Primary Hyperaldosteronism:

Diagnostic dose:

-Long test: 400 mg orally per day for 3 to 4 weeks

-Short test: 400 mg orally per day for 4 days

Maintenance dose: 100 to 400 mg orally per day until surgery; may be used long-term at the lowest effective dose in patients deemed unsuitable for surgery.

Comments:

-For the long test, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.

-For the short test, increased serum potassium with this drug and a decrease upon discontinuation provide presumptive evidence of primary hyperaldosteronism.

Uses:

-Initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

-Short-term preoperative treatment of patients with primary hyperaldosteronism.

-Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Usual Adult Dose for Hypokalemia:

25 to 100 mg orally per day

Uses:

-Treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate.

-Prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What to avoid

Drinking alcohol can increase certain side effects.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Aldactone side effects

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urination;
• high potassium level – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; o
• signs of other electrolyte imbalances – increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common Aldactone side effects may include:

• breast swelling or tenderness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Aldactone?

Using Aldactone with other drugs that make you dizzy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your other medicines, especially:

• colchicine;
• digoxin;
• lithium;
• loperamide;
• trimethoprim;
• heart or blood pressure medicine (especially another diuretic);
• medicine to prevent a blood clot; or